List of Excipients in Branded Drug DG HEALTH CLEARLAX

Generic Drugs Containing DG HEALTH CLEARLAX

Company	Ingredient	NDC	Excipient
Dolgencorp Inc	polyethylene glycol 3350	55910-846	SUCRALOSE

What are the Most Frequently-Used Excipients in DG HEALTH CLEARLAX?

# Of NDCs	Excipient
1	SUCRALOSE

DG Health ClearLax Excipient Strategy and Commercial Opportunities

Last updated: August 9, 2026

DG Health ClearLax is an OTC polyethylene glycol 3350 laxative positioned as a lower-priced private-label alternative to MiraLAX. Its formulation is unusually simple: the drug product is typically polyethylene glycol 3350 powder with no declared inactive ingredients. Commercial opportunity therefore depends less on novel excipient chemistry and more on dose presentation, taste masking, packaging, channel economics, regulatory compliance, and private-label distribution.

What is DG Health ClearLax?

DG Health ClearLax is an OTC powder for oral solution containing 17 grams of polyethylene glycol 3350 per dose. The product is sold through Dollar General stores under the DG Health private-label brand and is marketed for occasional constipation relief.

Attribute	DG Health ClearLax
Brand owner/channel	Dollar General private label
Active ingredient	Polyethylene glycol 3350
Dose	17 g per adult dose
Dosage form	Powder for oral solution
FDA category	OTC laxative
Typical onset	One to three days
Primary comparator	MiraLAX
Core excipients	Product labeling generally identifies no inactive ingredients
Primary commercial channel	Dollar General retail stores and digital commerce
Biosimilar relevance	None
Main competitive risk	Store-brand and branded PEG 3350 alternatives

Polyethylene glycol 3350 is an osmotic laxative. It retains water in the stool and increases stool water content without relying on intestinal stimulation. The FDA OTC monograph framework permits polyethylene glycol 3350 for occasional constipation at a 17-gram daily dose in adults and children aged 17 years and older, subject to labeling requirements (21 C.F.R. § 331.40).

What excipients are used in DG Health ClearLax?

The principal excipient strategy is excipient minimization. Polyethylene glycol 3350 is both the active pharmaceutical ingredient and the bulk powder carrier. The product generally contains no flavoring, coloring, sweetener, preservative, or suspending agent.

Formulation composition

Component	Functional role	Strategic assessment
Polyethylene glycol 3350	Active ingredient and water-retaining osmotic agent	Determines efficacy, dose, molecular-weight profile, and powder handling
Flavoring	Not generally listed	Lowers cost but may reduce palatability for some users
Sweetener	Not generally listed	Avoids sugar and high-intensity sweetener cost
Colorant	Not generally listed	Supports a clear, beverage-compatible solution
Preservative	Not generally listed for the dry powder	Appropriate because the product is reconstituted immediately before use
Flow aid	Not generally listed	Manufacturing may require control of particle size and moisture without a declared formulation excipient
Packaging desiccant	May be used depending on package configuration	Protects powder flow and dose uniformity but is not part of the administered formulation

The absence of inactive ingredients creates a short label and reduces risks associated with allergen declarations, excipient intolerance, and formulation complexity. It also limits opportunities to differentiate the base product through composition alone.

Why excipient simplicity matters commercially

A minimal formulation can produce several advantages:

1. Lower raw-material and blending costs.
2. Fewer quality-control tests for formulation ingredients.
3. Lower risk of incompatibility, color change, or flavor instability.
4. Easier private-label sourcing from multiple contract manufacturers.
5. Straightforward comparison with leading PEG 3350 products.
6. Reduced packaging and regulatory complexity.

The tradeoff is that the product has few formulation-based barriers to substitution. Competitors can reproduce the same active ingredient, dose, and powder format with limited technical difficulty.

What is the FDA regulatory status of DG Health ClearLax?

DG Health ClearLax is regulated as an OTC laxative using the FDA monograph framework for polyethylene glycol 3350 products. The relevant FDA conditions address active ingredient, dose, indications, warnings, directions, and labeling.

FDA labeling requirements

The principal OTC labeling elements include:

• Relief of occasional constipation.
• A 17-gram dose dissolved in 4 to 8 ounces of beverage.
• Use once daily or as directed by a doctor.
• Expected bowel movement within one to three days.
• Warnings concerning rectal bleeding, nausea, abdominal pain, vomiting, kidney disease, and prolonged use.
• Age-related use restrictions.
• Directions to measure the dose using the supplied measuring device when applicable.

The product’s regulatory value comes from compliant OTC execution rather than from exclusivity. A private-label manufacturer generally competes through supply reliability, quality systems, cost, and retailer access.

What patents protect DG Health ClearLax?

No material active-ingredient patent estate is expected to protect DG Health ClearLax. Polyethylene glycol 3350 has been used in pharmaceutical products for decades, and the fundamental laxative use is not commercially protected by a current composition-of-matter patent.

Potential protection category	Relevance to ClearLax
Polyethylene glycol 3350 composition patent	No meaningful current exclusivity expected
Basic laxative method of use	Generally open to OTC competition
17-gram dose	Unlikely to provide enforceable product exclusivity by itself
Powder formulation	Low barrier unless a narrow, nonstandard formulation is claimed
Flavor system	Could be protected in a differentiated product, but not central to standard ClearLax
Packaging design	Potentially protectable through trade dress or design rights
Trademark	DG Health and ClearLax brand rights may protect commercial identity
Manufacturing process	Potentially confidential, but difficult to use as a broad market barrier
Distribution agreement	May provide channel control without creating drug patent exclusivity

Orange Book status

A conventional private-label PEG 3350 product marketed under the OTC monograph system should not be treated as having a conventional Orange Book patent listing comparable to a branded prescription drug. Orange Book exposure is therefore limited. The principal regulatory risk is failure to comply with monograph requirements, current good manufacturing practice rules, labeling standards, or product-quality obligations.

A competitor would not normally need to file a Paragraph IV certification to launch a compliant OTC PEG 3350 product marketed under the same monograph conditions. Paragraph IV litigation is primarily relevant to approved prescription products with listed patents under an abbreviated new drug application pathway.

When does DG Health ClearLax lose exclusivity?

DG Health ClearLax has no conventional market exclusivity period comparable to new chemical entity exclusivity, pediatric exclusivity, or an innovative prescription-drug patent term. Its commercial protection is based on private-label branding and retail placement.

Exclusivity profile

Exclusivity mechanism	Expected status
New chemical entity exclusivity	Not applicable
Five-year approval exclusivity	Not applicable to the standard OTC monograph product
Three-year clinical-investigation exclusivity	Not applicable
Pediatric exclusivity	Not identified
Patent-based exclusivity	No material product exclusivity expected
OTC monograph access	Permits broad compliant competition
Private-label exclusivity	Commercial and contractual rather than statutory
Retail placement	Controlled by the retailer and supplier agreements

A competing manufacturer can enter with a comparable PEG 3350 powder if it satisfies FDA requirements and avoids trademark, trade-dress, and packaging infringement.

What excipient strategies could improve ClearLax?

The strongest opportunities are incremental. A new formulation would need to preserve the clinical and regulatory advantages of PEG 3350 while improving consumer experience or retail economics.

Flavor and palatability systems

Standard PEG 3350 powder is designed to dissolve in beverages without materially changing taste. Some consumers still report an unpleasant mouthfeel or difficulty incorporating the powder into drinks. A light flavor system could support:

• Lemon-lime or berry variants.
• Child-oriented formulations where permitted by labeling.
• Single-serve stick packs.
• Premium versions with improved dissolution and reduced residual texture.

Flavoring creates new regulatory and quality requirements. The flavor must be compatible with the dry powder, stable during shelf life, and accurately declared as an inactive ingredient.

Sweetener systems

A low-level sweetener could improve acceptance, but it would change the product’s clean-label profile. Potential options include sucralose, steviol glycosides, or sugar alcohols. Each introduces tradeoffs:

• Sucralose may improve taste at low concentrations but adds an inactive ingredient declaration.
• Steviol glycosides support a naturally positioned product but can produce bitterness.
• Sugar alcohols can create gastrointestinal concerns that conflict with a constipation product’s positioning.
• Sucrose or dextrose may improve taste but add calories and moisture sensitivity.

For a value retailer, flavorless and unsweetened remains the lowest-cost configuration.

Solubility and dispersion engineering

PEG 3350 dissolves in water and other beverages, but powder flow, clumping, and dose uniformity remain manufacturing concerns. Process improvements may include:

• Controlled particle-size distribution.
• Moisture-controlled blending.
• Agglomerated granules for improved dispersion.
• Better scoop geometry.
• Unit-dose sachets that reduce settling and measurement variability.

A process change can improve user experience without introducing multiple excipients. It may also reduce manufacturing losses and improve line speed.

Alternative excipient platforms

A manufacturer could create a differentiated PEG 3350 product using:

• Electrolytes for specific clinical or rehydration positioning.
• Fiber blends for combined laxative and dietary-fiber claims.
• Prebiotic ingredients.
• Flavor and sweetener systems.
• Effervescent dosage forms.
• Ready-to-drink liquid formats.
• Chewable or gummy formats.

These products would no longer be simple substitutes for standard ClearLax. They could require separate regulatory analysis, different labeling, stability programs, and potentially new clinical support.

What commercial opportunities exist for DG Health ClearLax?

The largest opportunities are channel expansion and packaging architecture rather than new active ingredients.

Private-label price architecture

Dollar General can use ClearLax to capture consumers who recognize MiraLAX but prefer a lower unit price. The retailer can offer multiple sizes:

Format	Commercial role
Small bottle or tub	Trial purchase and low out-of-pocket price
Standard 17-ounce or similar container	Core household product
Large value container	Higher margin and repeat-use segment
Single-dose packets	Travel, convenience, and impulse purchase
Twin-pack	Stock-up and basket-size growth
Premium flavored version	Higher price point

The active ingredient is inexpensive relative to branded OTC retail pricing. Packaging, retailer margin, logistics, and promotional allowances can have a greater effect on gross profit than the PEG 3350 itself.

E-commerce and omnichannel sales

PEG 3350 powder is suitable for online fulfillment because it is dry, nonrefrigerated, and relatively stable. Commercial expansion can include:

• Dollar General’s online store.
• Marketplace listings.
• Subscription replenishment.
• Search advertising against "MiraLAX alternative."
• Digital coupons tied to household health purchases.
• Cross-selling with tissues, hydration products, and digestive-health items.

The main online risk is price transparency. Consumers can compare ClearLax with retailer brands from Walmart, CVS, Walgreens, Amazon, and grocery chains.

Institutional and professional channels

Private-label PEG 3350 may have applications in:

• Long-term-care facilities.
• Hospital outpatient pharmacies.
• Correctional-health systems.
• Occupational-health clinics.
• Medicaid and managed-care formularies.
• Employer-sponsored retail health programs.

Institutional buyers prioritize unit cost, supply continuity, packaging efficiency, and documented quality systems. A single-serve packet or large-volume container can be more commercially valuable than a novel excipient.

How does ClearLax compare with MiraLAX and other PEG 3350 products?

ClearLax and MiraLAX are close substitutes when they contain the same active ingredient at the same 17-gram dose.

Factor	DG Health ClearLax	MiraLAX	Other store brands
Active ingredient	PEG 3350	PEG 3350	Usually PEG 3350
Standard dose	17 g	17 g	Usually 17 g
Brand position	Value/private label	National brand	Value/private label
Formulation differentiation	Limited	Limited in standard powder	Limited
Consumer trust	Retailer-dependent	High brand recognition	Retailer-dependent
Price	Generally lower	Generally higher	Competitive
Patent barrier	Low	Low for standard product	Low
Main advantage	Retail price and Dollar General access	Brand awareness and distribution	Price competition
Main weakness	Limited formulation differentiation	Higher price	Lower brand recognition

The strongest competitive distinction is not pharmacology. It is brand recognition, shelf placement, price, pack size, and retailer convenience.

What generic entry risks exist for ClearLax?

Generic and private-label entry risk is high because the market is technically accessible and the product has no meaningful current composition-of-matter barrier.

Primary entry risks

1. Large retailers can launch equivalent PEG 3350 products.
2. National brands can discount aggressively.
3. Contract manufacturers can supply multiple private labels.
4. Online sellers can compete on price and pack size.
5. Retailers can replace ClearLax with a higher-margin house brand.
6. Consumer switching costs are low.

Manufacturing and IP barriers

Manufacturing barriers are moderate rather than high. The product requires validated control of identity, assay, particle size, moisture, microbial quality, packaging, and dose uniformity. PEG 3350 is hygroscopic, so packaging performance and storage conditions matter. These requirements create quality and supply-chain discipline but do not generally prevent a capable OTC manufacturer from entering.

Potentially protectable areas include a specialized sachet, novel flavor system, low-dust granulation process, child-resistant package, or improved measuring device. These protections would be narrow and would not block standard PEG 3350 powder competition.

What patent litigation and Paragraph IV challenges affect ClearLax?

No major Paragraph IV litigation is expected to be central to the standard DG Health ClearLax product. A compliant OTC monograph product generally does not depend on a patent-protected prescription approval.

Litigation risk is more likely to involve:

• Trademark disputes concerning ClearLax or DG Health branding.
• Trade-dress disputes involving package appearance.
• Contract disputes with contract manufacturers.
• Product-liability claims.
• FDA enforcement involving labeling, contamination, misbranding, or manufacturing controls.
• Supplier disputes involving PEG 3350 specifications or shortages.

A formulation company launching an enhanced PEG 3350 product could face patent litigation if it claims a narrowly defined excipient system or delivery platform. That risk would attach to the improved formulation, not to conventional PEG 3350 powder.

Are licensing deals relevant to DG Health ClearLax?

Licensing is not a major requirement for the standard product. Dollar General or its supplier can procure PEG 3350 and manufacture under an OTC-compliant arrangement without licensing a branded drug patent.

Commercial agreements may still cover:

• Private-label manufacturing.
• Trademark use.
• Packaging and artwork.
• Supply commitments.
• Quality agreements.
• Forecasting and minimum purchase volumes.
• Recall allocation.
• Product-liability insurance.
• Geographic and channel restrictions.

A licensing opportunity could arise for an improved delivery format, proprietary flavor system, child-friendly presentation, or integrated digital adherence package. The license would provide commercial differentiation, not access to the basic PEG 3350 molecule.

What is the revenue exposure for DG Health ClearLax?

Dollar General does not generally report ClearLax revenue as a separate public line item. Revenue exposure must therefore be evaluated through category economics rather than product-level disclosure.

The relevant commercial drivers are:

• Store count and distribution breadth.
• Unit velocity per store.
• Average retail price.
• Gross margin after supplier cost.
• Promotion frequency.
• Seasonal constipation demand.
• Stock-up behavior.
• Online conversion.
• Retailer substitution decisions.

The product is likely to have modest direct revenue relative to Dollar General’s total sales, but it can contribute to the health-and-personal-care category, customer retention, and private-label margin. A differentiated format could raise revenue per facing, while a basic equivalent product is more likely to compete on price and volume.

What is the commercial outlook for excipient innovation?

The best near-term opportunity is a tiered portfolio:

Tier	Product concept	Strategic objective
Value	Unflavored PEG 3350 powder	Protect price-sensitive volume
Convenience	Unit-dose stick packs	Improve portability and dosing
Premium	Flavored, fast-dispersing powder	Raise price and margin
Family	Consumer-friendly format with simplified dosing	Expand household use, subject to labeling
Institutional	Large container or multi-dose facility pack	Lower cost per administered dose
Adjacent digestive health	PEG 3350 combined with fiber or prebiotic ingredients	Build broader category platform

The value product should remain formulation-simple. Excipient investment is more justified in premium or convenience extensions, where better taste, dosing, or portability can support a higher retail price.

Key Takeaways

• DG Health ClearLax is a polyethylene glycol 3350 OTC laxative, generally dosed at 17 grams.
• Its formulation strategy is based on minimal excipients and low manufacturing complexity.
• Standard ClearLax has little expected patent or regulatory exclusivity beyond compliant OTC monograph marketing.
• Paragraph IV challenges and biosimilar risk are not central to the product.
• The main competitive risks are private-label substitution, branded discounting, and retailer shelf reallocation.
• The strongest commercial opportunities are unit-dose packaging, flavored variants, e-commerce, institutional supply, and tiered private-label pricing.
• Manufacturing quality, moisture control, packaging, and supply reliability are more important barriers than active-ingredient IP.
• Any premium formulation should be evaluated for new labeling, stability, quality, and potential patent requirements.

FAQs

Can DG Health ClearLax be reformulated with flavoring?

Yes. Flavoring can improve consumer acceptance, but it would require inactive-ingredient declaration, compatibility testing, stability data, and revised labeling.

Does PEG 3350 require a biosimilar pathway?

No. PEG 3350 is a synthetic small-molecule polymer, not a biologic. Biosimilar regulation is not applicable.

Can a retailer launch a competing product without a Paragraph IV filing?

Generally yes, if the product is marketed under applicable OTC monograph conditions and does not infringe trademark, trade dress, or any valid formulation patent.

Is a single-dose ClearLax packet commercially attractive?

Yes. Stick packs can improve portability, dose consistency, e-commerce fulfillment, and institutional dispensing. The economics depend on packaging cost and retail price premium.

Could electrolytes create a defensible ClearLax extension?

Electrolytes could differentiate the product, but they would create a materially different formulation and require careful assessment of claims, safety, labeling, stability, and potential rehydration-product regulation.

References

1. Code of Federal Regulations. (2024). 21 C.F.R. § 331.40, Active ingredients for use in laxative drug products for oral administration. U.S. Food and Drug Administration.

2. Dollar General Corporation. (n.d.). DG Health ClearLax polyethylene glycol 3350 powder product labeling. Dollar General.

3. U.S. Food and Drug Administration. (2019). Drug facts label requirements for over-the-counter human drug products. 21 C.F.R. § 201.66.

4. U.S. Food and Drug Administration. (2024). Over-the-counter monograph M007: Laxative drug products for oral administration. U.S. Department of Health and Human Services.

5. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. Center for Drug Evaluation and Research.