Over-the-counter drug · OTC MONOGRAPH DRUG
TopCare health NIGHTTIME MAXIMUM STRENGTH Sleep Aid (Diphenhydramine hydrochloride) NDC 76162-438
Diphenhydramine hydrochloride 50 mg/1 · Capsule, Liquid filled · Oral · Topco Associates LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76162-438-96 | 7616204389676162043896 | 96 CAPSULE, LIQUID FILLED in 1 BOTTLE (76162-438-96)Marketed from Aug 1, 2025 |
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 health NIGHTTIME MAXIMUM STRENGTH Sleep Aid
- 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 76162
- 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 76162-438_267da9a1-6c85-4316-9aad-3fe5762c347aSPL ID 267da9a1-6c85-4316-9aad-3fe5762c347aSPL set ID 2ea0b2cf-f055-11f6-e063-6394a90a5364RxCUI 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
N476162043896followed by a unit qualifier and the quantityPackage 76162-0438-96. 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.
About NDC 76162-438
- What is NDC 76162-438?
- 76162-438 is the product NDC for TopCare health NIGHTTIME MAXIMUM STRENGTH Sleep Aid, 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?
- TopCare health NIGHTTIME MAXIMUM STRENGTH Sleep Aid (Diphenhydramine hydrochloride).
- What is the active ingredient?
- Diphenhydramine hydrochloride.
- Who is the labeler?
- Topco Associates LLC, NDC labeler code 76162. 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 health NIGHTTIME MAXIMUM STRENGTH Sleep Aid?
- 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.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Diphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/1 | Capsule, Liquid filledOral | Softgel Healthcare Pvt Ltd | 35916-0472 |
| 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 |
| 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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