What is NDC 76281-522?

76281-522 is the product NDC for Nighttime Sleep-Aid Non-Habit Forming, Diphenhydramine hydrochloride 50 mg/30mL liquid, listed with the FDA by AptaPharma Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Nighttime Sleep-Aid Non-Habit Forming (Diphenhydramine HCI).

AptaPharma Inc., NDC labeler code 76281. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Nighttime Sleep-Aid Non-Habit Forming?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Nighttime Sleep-Aid Non-Habit Forming NDC 76281-522

NDC codes

FDA NDC Directory

Product NDC (as listed)76281-522Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76281-0522Add 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
76281-522-24	7628105222476281052224	118 mL in 1 BOTTLE (76281-522-24)Marketed from Jan 1, 2018
76281-522-25	7628105222576281052225	177 mL in 1 BOTTLE (76281-522-25)Marketed from Jan 1, 2018
76281-522-28	7628105222876281052228	354 mL in 1 BOTTLE (76281-522-28)Marketed from Jan 1, 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): Nighttime Sleep-Aid Non-Habit FormingSuffix: Non-Habit Forming
Generic name (nonproprietary): diphenhydramine hci
Active ingredients: Diphenhydramine hydrochloride — 50 mg/30mL
Dosage form: Liquid
Route: Oral
Labeler: AptaPharma Inc.NDC labeler code 76281
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 017
Marketing start: Jan 1, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 76281-522_f1654da1-64f7-4c2b-9201-3a7af430ba37SPL ID f1654da1-64f7-4c2b-9201-3a7af430ba37SPL set ID ed0ba7aa-e794-43da-b576-6b9945bf7477RxCUI 1248354UNII TC2D6JAD40UPC 0376281522242, 0376281522259
Pharmacologic class: Histamine-1 Receptor Antagonist

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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N476281052224 followed by a unit qualifier and the quantity

Package 76281-0522-24. 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 30, 2023.

Indications (excerpt from the label)

Uses ■ reduces time to fall asleep if you have difficulty falling asleep ■ for relief of occasional sleeplessness

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 76281-522

What is NDC 76281-522?: 76281-522 is the product NDC for Nighttime Sleep-Aid Non-Habit Forming, Diphenhydramine hydrochloride 50 mg/30mL liquid, listed with the FDA by AptaPharma Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Nighttime Sleep-Aid Non-Habit Forming (Diphenhydramine HCI).
What is the active ingredient?: Diphenhydramine hydrochloride.
Who is the labeler?: AptaPharma Inc., NDC labeler code 76281. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Nighttime Sleep-Aid Non-Habit Forming?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under M 017

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

FDA NDC Directory listings under M 017
Product	Strength	Form · route	Labeler	Product NDC
Extra Strength Itch Reliefdiphenhydramine hcl and zinc acetate	Diphenhydramine hydrochloride 20 mg/g; Zinc acetate 1 mg/g	SprayTopical	Meijer Distribution Inc	79481-0598
3X Medicated Toothache and Gum Gelbenzocaine	Benzocaine 20 g/100g + 2 more ingredients	GelOral	Rite Aid	11822-0613
Meijer Pain Relieving Balm Analgesictrolamine salicylate	Trolamine salicylate 10 mg/g	CreamTopical	Meijer Distribution, Inc	41250-356
Ralli Rapid Pain Relief Roll onmenthol	Menthol 100 mg/mL	GelTopical	Troy Manufacturing, Inc.	63936-9527
CVS Health Pain Relievingcamphor (synthetic), menthol (unspecified form), methyl salicylate	Camphor (Synthetic) 28 mg/1 + 2 more ingredients	PatchTransdermal	Natural Essentials, Inc.	66902-280
Pbz Otctripelennamine hcl 1%	Tripelennamine 1 g/100g	CreamTopical	Kingsway Pharmaceuticals dba NFI, LLC	69993-151
Hydrocortisone	Hydrocortisone 1 g/100g	CreamTopical	Henry Schein	0404-0166
American Safety and First Aidhydrocortisone acetate	Hydrocortisone acetate 10 mg/g	CreamTopical	Orazen Inc	71927-015
MyDerm Bite Reliefbenzocaine	Benzocaine 5 g/100g	OintmentTopical	Inspec Solutions LLC.	72667-019
Thera Plus Maximum Strength Hydrocortisonehydrocortisone	Hydrocortisone 10 mg/g	CreamTopical	Fourstar Group USA, Inc	80684-197
Lidocaine 4%	Lidocaine 400 mg/10g	PatchTransdermal	Marcella Health	85096-201
Tough Love Pain Relievinglidocaine hcl	Lidocaine 4 g/100g	CreamTopical	Allure Labs	62742-4222
Stopain Extra Strength Gelmenthol	Menthol 80 mg/mL	GelTopical	Troy Manufacturing, Inc.	63936-9506
Fast Freeze Lidocaine Roll-Onlidocaine hydrochloride, benzyl alcohol	Lidocaine hydrochloride 40 mg/mL; Benzyl alcohol 10 mg/mL	LiquidTopical	Natural Essentials, Inc.	66902-235
Walgreens pain relievinglidocaine 4%	Lidocaine 4 g/100g	Aerosol, SprayTopical	Walgreens	0363-3038
Bikini Zone Medicated Cremelidocaine	Lidocaine 2 g/100g	CreamTopical	Kingsway Pharmaceuticals dba NFI, LLC	69993-043
American Safety First Aidlidocaine hcl	Lidocaine hydrochloride 20 mg/mL	SprayTopical	Orazen Inc	71927-012
ACOLYE Lidocaine Cream Topical Analgesia Creamlidocaine,menthol	Lidocaine 4 g/100g; Menthol 1 g/100g	CreamTopical	Guangdong Aimu Biological Technology Co., Ltd	83566-617
Healmusz Eczemahydrocortisone 1% eczema	Hydrocortisone 1 g/100g	CreamTopical	Jiangxi Yudexi Pharmaceutical Co., LTD	85248-203
ELAIMEI Numbing Creamlidocaine 4%	Lidocaine 4 g/100mL	CreamTopical	Shenzhen Shandian Jingling Technology Co., Ltd.	83804-005

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Nighttime Sleep-Aid Non-Habit Forming (Diphenhydramine hci) NDC 76281-522