What is NDC 36800-431?

36800-431 is the product NDC for topcare sleep aid nighttime (diphenhydramine hydrochloride), Diphenhydramine hydrochloride 25 mg/1 tablet, film coated, listed with the FDA by Topco Associates LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

topcare sleep aid nighttime (Diphenhydramine Hydrochloride).

Topco Associates LLC, NDC labeler code 36800. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for topcare sleep aid nighttime?

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.

topcare sleep aid nighttime NDC 36800-431

NDC codes

FDA NDC Directory

Product NDC (as listed)36800-431Labeler and product segments. Claims need a package NDC.

Product NDC at billing width36800-0431Add 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
36800-431-62	3680004316236800043162	12 BLISTER PACK in 1 CARTON (36800-431-62) / 2 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Sep 11, 2001
36800-431-67	3680004316736800043167	24 BLISTER PACK in 1 CARTON (36800-431-67) / 2 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jan 27, 2004
36800-431-78	3680004317836800043178	1 BOTTLE in 1 CARTON (36800-431-78) / 100 TABLET, FILM COATED in 1 BOTTLEMarketed from Sep 13, 2017

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): topcare sleep aid nighttimeSuffix: nighttime
Generic name (nonproprietary): diphenhydramine hydrochloride
Active ingredients: Diphenhydramine hydrochloride — 25 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Topco Associates LLCNDC labeler code 36800
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 010
Marketing start: Sep 11, 2001
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 36800-431_b0cba6ea-b6ae-42a0-aaae-055d03fb8254SPL ID b0cba6ea-b6ae-42a0-aaae-055d03fb8254SPL set ID 30284271-0411-4abf-bc62-d956dc794432RxCUI 1049630UNII TC2D6JAD40
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

N436800043162 followed by a unit qualifier and the quantity

Package 36800-0431-62. 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 Jul 17, 2024.

Indications (excerpt from the label)

Use 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 36800-431

What is NDC 36800-431?: 36800-431 is the product NDC for topcare sleep aid nighttime (diphenhydramine hydrochloride), Diphenhydramine hydrochloride 25 mg/1 tablet, film coated, listed with the FDA by Topco Associates LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: topcare sleep aid nighttime (Diphenhydramine Hydrochloride).
What is the active ingredient?: Diphenhydramine hydrochloride.
Who is the labeler?: Topco Associates LLC, NDC labeler code 36800. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for topcare sleep aid nighttime?: 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 010

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

FDA NDC Directory listings under M 010
Product	Strength	Form · route	Labeler	Product NDC
Vicks ZzzQuil Night Paindiphenhydramine hydrochloride and acetaminophen	Diphenhydramine hydrochloride 50 mg/30mL; Acetaminophen 1000 mg/30mL	LiquidOral	The Procter & Gamble Manufacturing Company	69423-985
Nighttime Sleep Aiddiphenhydramine hydrochloride	Diphenhydramine hydrochloride 50 mg/30mL	LiquidOral	BJWC (Berkley & Jensen / BJ's)	68391-793
Sleep Aiddiphenhydramine hcl	Diphenhydramine hydrochloride 50 mg/1	CapsuleOral	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	49035-736
Diphenhydramine HCl 25mgsleep aid	Diphenhydramine hydrochloride 25 mg/1	Tablet, CoatedOral	Allegiant Health	69168-002
berkley and jensen sleep aiddiphenhydramine hcl	Diphenhydramine hydrochloride 50 mg/30mL	SolutionOral	BJWC	68391-186
AXIV - VroZzzdiphenhydramine hydrochloride	Diphenhydramine hydrochloride 25 mg/1	Capsule, Liquid filledOral	Vivunt Pharma LLC	82706-014
Revasol Sleep Aiddiphenhydramine hcl	Diphenhydramine HCl 50 mg/30mL	LiquidOral	Rnv LLC	84379-284
Vicks ZzzQuil Night Paindiphenhydramine hydrochloride and acetaminophen	Diphenhydramine hydrochloride 25 mg/1; Acetaminophen 500 mg/1	Tablet, CoatedOral	The Procter & Gamble Manufacturing Company	37000-974
Nighttime sleep aid Maximum Strengthdiphenhydramine hydrochloride	Diphenhydramine hydrochloride 50 mg/1	Capsule, Liquid filledOral	Best Choice (Valu Merchandisers Company)	63941-860
Sleep Tabsdiphenhydramine hcl	Diphenhydramine hydrochloride 25 mg/1	TabletOral	Major Pharmaceuticals	0904-4274
Nightime Sleep Aiddiphenhydramine hydrochloride	Diphenhydramine hydrochloride 50 mg/30mL	LiquidOral	BETTER LIVING BRANDS LLC.	21130-711
Diphenhydramine HCl	Diphenhydramine HCl 50 mg/30mL	LiquidOral	BI-MART	37835-519
Sleep Aid NightTimediphenhydramine hcl	Diphenhydramine hydrochloride 25 mg/1	Tablet, Film coatedOral	Wal-Mart Stores Inc	49035-672
Nighttime sleep aid Maximum Strengthdiphenhydramine hydrochloride	Diphenhydramine hydrochloride 50 mg/1	Capsule, Liquid filledOral	Best Choice (Valu Merchandisers Company)	63941-916
Nighttime Sleep-Aiddiphenhydramine hcl	Diphenhydramine hydrochloride 50 mg/1	Capsule, Liquid filledOral	BIONPHARMA INC.	69452-427
Diphenhydramine Hydrochloride	Diphenhydramine hydrochloride 25 mg/1	Tablet, CoatedOral	AAA Pharmaceutical, Inc.	57344-091
Sleep Aid	Diphenhydramine hydrochloride 50 mg/1	Capsule, Liquid filledOral	Better Living Brands LLC	21130-052
Sleep Aiddiphenhydramine hcl	Diphenhydramine hydrochloride 50 mg/1	CapsuleOral	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	55910-894
Quality Choice Nighttime Sleep-Aiddiphenhydramine hydrochloride	Diphenhydramine hydrochloride 25 mg/1	Capsule, Liquid filledOral	Chain Drug Marketing Association, Inc.	63868-970
Nighttime Sleep Aiddiphenhydramine hcl 50mg	Diphenhydramine hydrochloride 50 mg/1	Capsule, Liquid filledOral	Grocery Outlet	85828-410

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topcare sleep aid nighttime (Diphenhydramine hydrochloride) NDC 36800-431