Over-the-counter drug · OTC MONOGRAPH DRUG

Diphenhydramine Hydrochloride NDC 35916-0470

Diphenhydramine hydrochloride 50 mg/1 · Capsule, Liquid filled · Oral · Softgel Healthcare Pvt Ltd

NDC codes

FDA NDC Directory
Product NDC (as listed)35916-0470Labeler and product segments. Claims need a package NDC.
Product NDC at billing width35916-0470Add 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
35916-0470-135916047001359160470011000 CAPSULE, LIQUID FILLED in 1 BAG (35916-0470-1)Marketed from Apr 22, 2025

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Diphenhydramine Hydrochloride
Generic name (nonproprietary)
diphenhydramine hydrochloride
Active ingredients
Diphenhydramine hydrochloride — 50 mg/1
Dosage form
Capsule, Liquid filled
Route
Oral
Labeler
Softgel Healthcare Pvt LtdNDC labeler code 35916
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 35916-0470_47c5c74b-1c7b-fdd7-e063-6394a90a86f0SPL ID 47c5c74b-1c7b-fdd7-e063-6394a90a86f0SPL set ID 335b09c6-ee5d-ebdf-e063-6294a90abd12RxCUI 1020477UNII 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

N435916047001 followed by a unit qualifier and the quantity

Package 35916-0470-01. 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)

Uses 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 35916-0470

What is NDC 35916-0470?
35916-0470 is the product NDC for Diphenhydramine Hydrochloride, Diphenhydramine hydrochloride 50 mg/1 capsule, liquid filled, listed with the FDA by Softgel Healthcare Pvt Ltd. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Diphenhydramine Hydrochloride.
What is the active ingredient?
Diphenhydramine hydrochloride.
Who is the labeler?
Softgel Healthcare Pvt Ltd, NDC labeler code 35916. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Diphenhydramine Hydrochloride?
77 other product NDCs are listed under this name. See all Diphenhydramine Hydrochloride 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 Diphenhydramine Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Diphenhydramine HydrochlorideDiphenhydramine hydrochloride 25 mg/1TabletOralCardinal Health 107, LLC55154-158955154-1589-00
Diphenhydramine HydrochlorideDiphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralHealth Pharma USA LLC71679-30871679-0308-00
Diphenhydramine hydrochlorideDiphenhydramine hydrochloride 12.5 mg/5mLSolutionOralCamber Pharmaceuticals, Inc.31722-60031722-0600-1131722-0600-31
Diphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/10mLSolutionOralCamber Pharmaceuticals, Inc.31722-60131722-0601-31
Diphenhydramine HydrochlorideDiphenhydramine hydrochloride 50 mg/mLInjectionIntramuscular, IntravenousREMEDYREPACK INC.70518-453670518-4536-00
Diphenhydramine HydrochlorideDiphenhydramine hydrochloride 50 mg/mLInjectionIntramuscular, IntravenousHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-26323155-0263-31
Diphenhydramine HydrochlorideDiphenhydramine hydrochloride 50 mg/mLInjectionIntramuscular, IntravenousMicro Labs Limited42571-51142571-0511-56
Diphenhydramine hydrochlorideDiphenhydramine hydrochloride 50 mg/mLInjectionIntramuscular, IntravenousREMEDYREPACK INC.70518-445570518-4455-00
Diphenhydramine HydrochlorideDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralProdose, Inc.68210-505768210-5057-01
Diphenhydramine HydrochlorideDiphenhydramine hydrochloride 50 mg/mLInjectionIntramuscular, IntravenousHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-26423155-0264-41

All 78 Diphenhydramine Hydrochloride 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
Nighttime Sleep Aid maximum strengthdiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralCardinal Health (Leader) 7000070000-0527
Sleep Aid Nighttimediphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralBetter Living Brands, LLC21130-763
Vicks ZzzQuil Night Paindiphenhydramine hydrochloride and acetaminophenDiphenhydramine hydrochloride 50 mg/30mL; Acetaminophen 1000 mg/30mLLiquidOralThe Procter & Gamble Manufacturing Company69423-985
CVS NightTime Coldacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochlorideAcetaminophen 650 mg/30mL + 3 more ingredientsSolutionOralCVS PHARMACY51316-641
Nighttime Sleep-Aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralDISCOUNT DRUG MART, INC.53943-485
nighttime sleep aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/30mLSolutionOralAmazon.com Services LLC72288-765
Nighttime Sleep Aid Maximum Strengthdiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1CapsuleOralCare One (Retail Business Services, LLC.)72476-916
CalmCo Sleep Aid Gummy Bitediphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Bar, ChewableOralCalmCo LLC73282-2518
Diphenhydramine Hydrochloridediphenhydramine hydrochloride capsule, liquid filledDiphenhydramine hydrochloride 25 mg/1Capsule, Liquid filledOralAMZ789 LLC73629-007
Nightime Sleep Aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 50 mg/30mLLiquidOralBETTER LIVING BRANDS LLC.21130-711
Sleep Aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/30mLSolutionOralWalgreen Company0363-8020
Nighttime Sleep Aiddiphenhydramine hcl 50mgDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralGrocery Outlet85828-410
Sleep Aid NightTimediphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralWal-Mart Stores Inc49035-672
Good Sense Sleep Timediphenhydramine hclDiphenhydramine hydrochloride 50 mg/30mLSolutionOralL. Perrigo Company0113-0186
Diphenhydramine HClDiphenhydramine HCl 50 mg/30mLLiquidOralBI-MART37835-519
Calmco Sleep Aiddiphenhydramine hclDiphenhydramine hydrochloride 25 mg/5mLSolutionOralCalmCo LLC73282-2525
berkley and jensen sleep aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/30mLSolutionOralBJWC68391-186
Nighttime Sleep-Aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralBIONPHARMA INC.69452-427
Sleep Aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1CapsuleOralFamily Dollar (FAMILY WELLNESS)55319-564
Sleep Aid Maximum Strengthdiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1CapsuleOralQUALITY CHOICE (Chain Drug Marketing Association)63868-900

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