Over-the-counter drug · OTC MONOGRAPH DRUG
Unisom SleepMelts Nighttime Sleep-Aid (Diphenhydramine hydrochloride) NDC 63868-393
Diphenhydramine hydrochloride 25 mg/1 · Tablet, Chewable · Oral · QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63868-393-24 | 6386803932463868039324 | 24 TABLET, CHEWABLE in 1 BLISTER PACK (63868-393-24)Marketed from Jan 7, 2019 |
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)
- Unisom SleepMelts Nighttime Sleep-Aid
- Generic name (nonproprietary)
- diphenhydramine hydrochloride
- Active ingredients
- Diphenhydramine hydrochloride — 25 mg/1
- Dosage form
- Tablet, Chewable
- Route
- Oral
- Labeler
- QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)NDC labeler code 63868
- 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 63868-393_451d2a55-5219-9ce6-e063-6394a90a2d06SPL ID 451d2a55-5219-9ce6-e063-6394a90a2d06SPL set ID f50cc038-0973-4c4b-84a7-1c68f41c2410RxCUI 1093098, 1093102UNII TC2D6JAD40UPC 0635515996694
- 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
N463868039324followed by a unit qualifier and the quantityPackage 63868-0393-24. 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
Excerpt only. Read the full label for complete information.
About NDC 63868-393
- What is NDC 63868-393?
- 63868-393 is the product NDC for Unisom SleepMelts Nighttime Sleep-Aid, Diphenhydramine hydrochloride 25 mg/1 tablet, chewable, listed with the FDA by QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION). It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Unisom SleepMelts Nighttime Sleep-Aid (Diphenhydramine Hydrochloride).
- What is the active ingredient?
- Diphenhydramine hydrochloride.
- Who is the labeler?
- QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION), NDC labeler code 63868. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Unisom SleepMelts Nighttime Sleep-Aid?
- 1 other product NDC are listed under this name. See all Unisom SleepMelts Nighttime Sleep-Aid NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Unisom SleepMelts Nighttime Sleep-Aid products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Unisom SleepMelts Nighttime Sleep-Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, ChewableOral | Chattem, Inc. | 41167-0014 | 41167-0014-00 |
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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