Over-the-counter drug · OTC MONOGRAPH DRUG
Diphenhydramine hydrochloride NDC 35916-0472
Diphenhydramine hydrochloride 50 mg/1 · Capsule, Liquid filled · Oral · Softgel Healthcare Pvt Ltd
NDC codes
FDA NDC DirectoryProduct NDC (as listed)35916-0472Labeler and product segments. Claims need a package NDC.
Product NDC at billing width35916-0472Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 35916-0472-1 | 3591604720135916047201 | 1000 CAPSULE, LIQUID FILLED in 1 BAG (35916-0472-1)Marketed from Apr 8, 2025 | |
| 35916-0472-2 | 3591604720235916047202 | 2 POUCH in 1 BOX (35916-0472-2) / 3000 CAPSULE, LIQUID FILLED in 1 POUCHMarketed from Jul 16, 2025 | |
| 35916-0472-3 | 3591604720335916047203 | 2 BAG in 1 BOX (35916-0472-3) / 1500 CAPSULE, LIQUID FILLED in 1 BAGMarketed from Jan 24, 2026 |
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 35916-0472_47db0e8e-5351-a9ae-e063-6394a90aba50SPL ID 47db0e8e-5351-a9ae-e063-6394a90aba50SPL set ID 32033991-a4f0-f767-e063-6394a90a0b06RxCUI 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
N435916047201followed by a unit qualifier and the quantityPackage 35916-0472-01. 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.
About NDC 35916-0472
- What is NDC 35916-0472?
- 35916-0472 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 3 package NDCs, 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.
Related NDCs: other Diphenhydramine hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-1589 | 55154-1589-00 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Health Pharma USA LLC | 71679-308 | 71679-0308-00 |
| Diphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | SolutionOral | Camber Pharmaceuticals, Inc. | 31722-600 | 31722-0600-1131722-0600-31 |
| Diphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/10mL | SolutionOral | Camber Pharmaceuticals, Inc. | 31722-601 | 31722-0601-31 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 50 mg/mL | InjectionIntramuscular, Intravenous | REMEDYREPACK INC. | 70518-4536 | 70518-4536-00 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 50 mg/mL | InjectionIntramuscular, Intravenous | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-263 | 23155-0263-31 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 50 mg/mL | InjectionIntramuscular, Intravenous | Micro Labs Limited | 42571-511 | 42571-0511-56 |
| Diphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/mL | InjectionIntramuscular, Intravenous | REMEDYREPACK INC. | 70518-4455 | 70518-4455-00 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 50 mg/1 | Capsule, Liquid filledOral | Prodose, Inc. | 68210-5057 | 68210-5057-01 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 50 mg/mL | InjectionIntramuscular, Intravenous | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-264 | 23155-0264-41 |
Other NDCs under M 010
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Nighttime Sleep Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | TabletOral | Chain Drug Marketing Association | 63868-611 |
| Sleep Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | Shield Pharmaceuticals Corp | 83059-0075 |
| Wal Som Nighttime Sleep Aid Nighttimediphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/1 | CapsuleOral | Walgreens | 0363-0860 |
| Nighttime Sleep Aiddiphenhydramine hcl 25 mg | Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | Health Pharma USA LLC | 71679-110 |
| Sleep Aiddiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/1 | CapsuleOral | QUALITY CHOICE (Chain Drug Marketing Association) | 83324-151 |
| Nighttime Sleep Aiddiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/30mL | SolutionOral | H E B | 37808-186 |
| Nighttime Sleep Aid | Diphenhydramine hydrochloride 50 mg/30mL | LiquidOral | Allegiant Health | 69168-486 |
| Sleep Aid Night Timediphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | DOLGENCORP, LLC | 55910-687 |
| Sleep Aid | Diphenhydramine hydrochloride 50 mg/1 | Capsule, Liquid filledOral | Allegiant Health | 69168-917 |
| Nighttime Sleep Aiddiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Strategic Sourcing Services LLC | 70677-1128 |
| TopCare health NIGHTTIME MAXIMUM STRENGTH Sleep Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/1 | Capsule, Liquid filledOral | Topco Associates LLC | 76162-438 |
| Sleep Aid Maximum Strengthdiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/1 | CapsuleOral | H E B | 37808-860 |
| Nighttime Sleep Aid Alcohol Freediphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/30mL | SolutionOral | Wal-Mart Stores Inc | 49035-330 |
| Somnitabsdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | TabletOral | HARRIS TEETER | 72036-019 |
| Sleep Aiddiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Amerisource Bergen | 46122-651 |
| Vicks ZzzQuil Nighttime Sleep-Aiddiphenhydramine hydrochloride | — | Kit | The Procter & Gamble Manufacturing Company | 84126-306 |
| Nighttime SleepAiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | AMERIFOODS TRADING COMPANY | 61504-091 |
| Pharbedryldiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/1 | CapsuleOral | Pharbest Pharmaceuticals, Inc. | 16103-347 |
| Sleep Aiddiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Cardinal Health 110, LLC. DBA Leader | 70000-0244 |
| KROGER Nighttime Sleep-Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/30mL | LiquidOral | KROGER COMPANY | 41226-730 |
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