Over-the-counter drug · OTC MONOGRAPH DRUG
Nighttime Sleep-Aid Softgel (Diphenhydramine hydrochloride) NDC 51316-779
Diphenhydramine hydrochloride 25 mg/1 · Capsule, Liquid filled · Oral · CVS PHARMACY, INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51316-779-24 | 5131607792451316077924 | 2 BLISTER PACK in 1 CARTON (51316-779-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Jul 23, 2021 | |
| 51316-779-48 | 5131607794851316077948 | 4 BLISTER PACK in 1 CARTON (51316-779-48) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Jul 23, 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)
- Nighttime Sleep-Aid Softgel
- Generic name (nonproprietary)
- diphenhydramine hydrochloride
- Active ingredients
- Diphenhydramine hydrochloride — 25 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- CVS PHARMACY, INCNDC labeler code 51316
- 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 51316-779_abe76ad8-3da3-48f9-9704-d230e846a5e1SPL ID abe76ad8-3da3-48f9-9704-d230e846a5e1SPL set ID 8b0fa259-6702-4667-bac6-f7d0b0839ae0RxCUI 1049909UNII 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
N451316077924followed by a unit qualifier and the quantityPackage 51316-0779-24. 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 • reduces time to fall asleep if you have difficulty falling asleep
Excerpt only. Read the full label for complete information.
About NDC 51316-779
- What is NDC 51316-779?
- 51316-779 is the product NDC for Nighttime Sleep-Aid Softgel (diphenhydramine hydrochloride), Diphenhydramine hydrochloride 25 mg/1 capsule, liquid filled, listed with the FDA by CVS PHARMACY, INC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nighttime Sleep-Aid Softgel (Diphenhydramine Hydrochloride).
- What is the active ingredient?
- Diphenhydramine hydrochloride.
- Who is the labeler?
- CVS PHARMACY, INC, NDC labeler code 51316. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nighttime Sleep-Aid Softgel?
- 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 |
|---|---|---|---|---|
| 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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