Over-the-counter drug · OTC MONOGRAPH DRUG

Sleep Aid Nighttime (Diphenhydramine hydrochloride) NDC 36800-784

Diphenhydramine hydrochloride 50 mg/1 · Capsule, Liquid filled · Oral · TOPCO ASSOCIATES LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)36800-784Labeler and product segments. Claims need a package NDC.
Product NDC at billing width36800-0784Add 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 NDC11-digit (billing)PackageCopy
36800-784-96368000784963680007849696 CAPSULE, LIQUID FILLED in 1 BOTTLE (36800-784-96)Marketed from May 1, 2021

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)
Sleep Aid Nighttime
Generic name (nonproprietary)
diphenhydramine hydrochloride
Active ingredients
Diphenhydramine hydrochloride — 50 mg/1
Dosage form
Capsule, Liquid filled
Route
Oral
Labeler
TOPCO ASSOCIATES LLCNDC labeler code 36800
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 010
Marketing start
Listing expires
Other FDA classes
Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 36800-784_fcc77456-2add-4ebd-be0f-e744101db96eSPL ID fcc77456-2add-4ebd-be0f-e744101db96eSPL set ID 9f1c078d-e537-4ec0-8ae9-54c98282be29UNII 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

N436800078496 followed by a unit qualifier and the quantity

Package 36800-0784-96. 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 .

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 36800-784

What is NDC 36800-784?
36800-784 is the product NDC for Sleep Aid Nighttime (diphenhydramine hydrochloride), Diphenhydramine hydrochloride 50 mg/1 capsule, liquid filled, listed with the FDA by TOPCO ASSOCIATES LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
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 Sleep Aid Nighttime?
14 other product NDCs are listed under this name. See all Sleep Aid Nighttime 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 Sleep Aid Nighttime NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Sleep Aid Nighttimediphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-36751316-0367-12
Sleep Aid NightTimediphenhydramine hclDiphenhydramine hydrochloride 50 mg/30mLLiquidOralDolgencorp, Inc. (DOLLAR GENERAL & REXALL)55910-98155910-0981-0255910-0981-04
Sleep Aid Nighttimediphenhydramine hclDiphenhydramine hydrochloride 50 mg/1CapsuleOralUnited Natural Foods, Inc. dba UNFI41163-86041163-0860-3241163-0860-96
Sleep Aid Nighttimediphenhydramine hclDiphenhydramine hydrochloride 50 mg/1CapsuleOralDolgencorp, Inc. (DOLLAR GENERAL & REXALL)55910-91655910-0916-1255910-0916-1655910-0916-32+2 more
Sleep Aid Nighttimediphenhydramine hclDiphenhydramine hydrochloride 50 mg/1CapsuleOralCVS Pharmacy69842-86069842-0860-3269842-0860-6469842-0860-96
Sleep Aid Nighttimediphenhydramine hclDiphenhydramine hydrochloride 50 mg/1CapsuleOralCVS Pharmacy69842-91669842-0916-0269842-0916-3269842-0916-64+1 more
Sleep Aid NightTimediphenhydramine hclDiphenhydramine hydrochloride 50 mg/30mLLiquidOralDolgencorp, Inc. (DOLLAR GENERAL & REXALL)55910-89955910-0899-12
Sleep Aid NightTimediphenhydramine hclDiphenhydramine hydrochloride 50 mg/30mLLiquidOralP & L Development, LLC49580-031449580-0314-0249580-0314-0449580-0314-06
Sleep Aid NightTimediphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralWal-Mart Stores Inc49035-67249035-0672-51
Sleep-Aid Nighttimediphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralCVS PHARMACY69842-67269842-0672-51

All 15 Sleep Aid Nighttime NDCs

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
ProductStrengthForm · routeLabelerProduct NDC
Vicks ZzzQuil Night Paindiphenhydramine hydrochloride and acetaminophenDiphenhydramine hydrochloride 50 mg/30mL; Acetaminophen 1000 mg/30mLLiquidOralThe Procter & Gamble Manufacturing Company69423-985
Nighttime Sleep Aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 50 mg/30mLLiquidOralBJWC (Berkley & Jensen / BJ's)68391-793
Sleep Aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1CapsuleOralEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)49035-736
Diphenhydramine HCl 25mgsleep aidDiphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralAllegiant Health69168-002
berkley and jensen sleep aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/30mLSolutionOralBJWC68391-186
AXIV - VroZzzdiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Capsule, Liquid filledOralVivunt Pharma LLC82706-014
Revasol Sleep Aiddiphenhydramine hclDiphenhydramine HCl 50 mg/30mLLiquidOralRnv LLC84379-284
Vicks ZzzQuil Night Paindiphenhydramine hydrochloride and acetaminophenDiphenhydramine hydrochloride 25 mg/1; Acetaminophen 500 mg/1Tablet, CoatedOralThe Procter & Gamble Manufacturing Company37000-974
Nighttime sleep aid Maximum Strengthdiphenhydramine hydrochlorideDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralBest Choice (Valu Merchandisers Company)63941-860
Sleep Tabsdiphenhydramine hclDiphenhydramine hydrochloride 25 mg/1TabletOralMajor Pharmaceuticals0904-4274
Nightime Sleep Aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 50 mg/30mLLiquidOralBETTER LIVING BRANDS LLC.21130-711
Diphenhydramine HClDiphenhydramine HCl 50 mg/30mLLiquidOralBI-MART37835-519
Sleep Aid NightTimediphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralWal-Mart Stores Inc49035-672
Nighttime sleep aid Maximum Strengthdiphenhydramine hydrochlorideDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralBest Choice (Valu Merchandisers Company)63941-916
Nighttime Sleep-Aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralBIONPHARMA INC.69452-427
Diphenhydramine HydrochlorideDiphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralAAA Pharmaceutical, Inc.57344-091
Sleep AidDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralBetter Living Brands LLC21130-052
Sleep Aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1CapsuleOralDolgencorp, Inc. (DOLLAR GENERAL & REXALL)55910-894
Quality Choice Nighttime Sleep-Aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Capsule, Liquid filledOralChain Drug Marketing Association, Inc.63868-970
Nighttime Sleep Aiddiphenhydramine hcl 50mgDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralGrocery Outlet85828-410

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