What is NDC 68016-054?

68016-054 is the product NDC for Hemorroidal Cooling gel, Witch hazel .5 g/100g; Phenylephrine hydrochloride .25 g/100g gel, listed with the FDA by Pharmacy Value Alliance, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Hemorroidal Cooling gel (Phenylephrine, Witch Hazel).

What is the active ingredient?

Witch hazel, Phenylephrine hydrochloride.

Pharmacy Value Alliance, LLC, NDC labeler code 68016. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Hemorroidal Cooling gel?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Hemorroidal Cooling gel NDC 68016-054

NDC codes

FDA NDC Directory

Product NDC (as listed)68016-054Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68016-0054Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
68016-054-09	6801600540968016005409	1 TUBE in 1 BOX (68016-054-09) / 26 g in 1 TUBEMarketed from Aug 2, 2018

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Hemorroidal Cooling gel
Generic name (nonproprietary): phenylephrine, witch hazel
Active ingredients: Witch hazel — .5 g/100gPhenylephrine hydrochloride — .25 g/100g
Dosage form: Gel
Route: Topical
Labeler: Pharmacy Value Alliance, LLCNDC labeler code 68016
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 015
Marketing start: Aug 2, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha1-Agonists (Mechanism)
Identifiers: Product ID 68016-054_29b73242-ddd9-37e0-e063-6394a90a7da9SPL ID 29b73242-ddd9-37e0-e063-6394a90a7da9SPL set ID 7276aab8-0297-2a55-e053-2a91aa0a8d21UNII 101I4J0U34, 04JA59TNSJ
Pharmacologic class: alpha-1 Adrenergic Agonist

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N468016005409 followed by a unit qualifier and the quantity

Package 68016-0054-09. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Dec 20, 2024.

Indications (excerpt from the label)

Uses Helps relieve the local itching and discomfort associated with hemorrhoids temporarily relief of irritation and burning temporarily shrinks hemorrhoidal tissue aids in protecting irritated anorectal areas

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68016-054

What is NDC 68016-054?: 68016-054 is the product NDC for Hemorroidal Cooling gel, Witch hazel .5 g/100g; Phenylephrine hydrochloride .25 g/100g gel, listed with the FDA by Pharmacy Value Alliance, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Hemorroidal Cooling gel (Phenylephrine, Witch Hazel).
What is the active ingredient?: Witch hazel, Phenylephrine hydrochloride.
Who is the labeler?: Pharmacy Value Alliance, LLC, NDC labeler code 68016. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Hemorroidal Cooling gel?: 1 other product NDC are listed under this name. See all Hemorroidal Cooling gel NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Hemorroidal Cooling gel NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Hemorroidal Cooling gelphenylephrine, witch hazel	Witch hazel .5 g/100g; Phenylephrine hydrochloride .25 g/100g	GelTopical	Trifecta Pharmaceuticals Usa Llc	69396-032	69396-0032-18

Other NDCs under M 015

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under M 015
Product	Strength	Form · route	Labeler	Product NDC
0.25 % PHENYLEPHRINE HCl HEMORRHOIDALmineral oil, petrolatum, phenylephrine hydrochloride	Mineral oil 14 g/100g + 2 more ingredients	OintmentTopical	Nantong Health & Beyond Hygienic Products Inc.	43473-094
0.25 % PHENYLEPHRINE HCl HEMORRHOIDALmineral oil, petrolatum, phenylephrine hydrochloride	Mineral oil 14 g/100g + 2 more ingredients	OintmentTopical	Universal Distribution Center LLC	52000-438
5% Lidocaine 10g5% lidocaine	Lidocaine 5 g/100g	CreamTopical	Chongqing Mandongzi Technology Co., Ltd	88002-001
Acolye Numbing Cream Anorectal(Hemorrhoidal) Creamlidocaine	Lidocaine 5 g/100g	CreamTopical	Guangzhou Haishi Biological Technology Co., Ltd.	60771-0028
Acolye Numbing Cream Anorectal(Hemorrhoidal) Creamlidocaine	Lidocaine 5 g/100g	CreamTopical	Guangzhou Haishi Biological Technology Co., Ltd.	60771-0029
Acolye Numbing Cream Anorectal(Hemorrhoidal) Creamlidocaine	Lidocaine 5 g/100g	CreamTopical	Guangdong Aimu Biological Technology Co., Ltd	83566-615
Adellina Lidocaine Numbing Cream Anorectal(Hemorrhoidal) Creamlidocaine	Lidocaine 5 g/100g	CreamTopical	Guangzhou Haishi Biological Technology Co., Ltd.	60771-0041
Adellina Lidocaine Numbing Cream Topical Anorectal Creamlidocaine	Lidocaine 5 g/100g	CreamTopical	Guangdong Aimu Biological Technology Co., Ltd	83566-612
Adellina Lidocaine Numbing Cream Topical Anorectal Creamlidocaine	Lidocaine 5 g/100g	CreamTopical	Guangdong Aimu Biological Technology Co., Ltd	83566-614
ADVANCED NUMB Topical Anestheticlidocaine hydrochloride	Lidocaine hydrochloride 50 mg/g	CreamTopical	Uber Scientific, LLC	71131-052
AER Pre-moistened Witch Hazel Padwitch hazel	Witch hazel 500 mg/mL	SolutionRectal, Topical	Birchwood Laboratories LLC	50289-3250
AER Traveler Toweletteaer traveler	Witch hazel .5 g/1	SolutionRectal, Topical	Birchwood Laboratories LLC	50289-4200
Americainebenzocaine	Benzocaine 5.6 g/28g	OintmentTopical	Insight Pharmaceuticals LLC	63736-375
AnievaLClidocaine	Lidocaine .05 g/g	CreamTopical	Blackstone Products, LLC	87798-001
ANIXIKE Numbinglidocaine4% numbing	Lidocaine 4 g/100g	CreamTopical	Jiangxi Yudexi Pharmaceutical Co., LTD	85248-166
Arlun LIDOCAINE Creamlidocaine cream	Lidocaine 5 g/100g	CreamTopical	Guangzhou Jingliang Cosmetics Co., Ltd.	87408-021
Assured Bikini Smooth Creamlidocaine	Lidocaine 2 g/100g	CreamTopical	Zhejiang Jingwei Pharmaceutical Co., Ltd.	55621-011
Asteroidmenthol, petrolatum, zinc oxide	Menthol .098 g/28g + 2 more ingredients	OintmentTopical	HEALTHTEX LIMITED	84107-552
B-SURE Traveler Toweletteb-sure traveler	Witch hazel .5 g/g	SolutionRectal, Topical	Birchwood Laboratories LLC	50289-9250
Barrier Protectant Creambarrier cream	Menthol 1 mg/g; Zinc oxide 200 mg/g	OintmentTopical	Cardinal Health	63517-003

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Hemorroidal Cooling gel (Phenylephrine, witch hazel) NDC 68016-054

NDC codes

Product information

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Product label

About NDC 68016-054

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NDC codes

Product information

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Product label

About NDC 68016-054

Related NDCs: other Hemorroidal Cooling gel products

Other NDCs under M 015