Over-the-counter drug · OTC MONOGRAPH DRUG
Topcare ZZZ Sleep (Diphenhydramine hcl) NDC 36800-200
Diphenhydramine hydrochloride 50 mg/30mL · Solution · Oral · Topco Associates LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36800-200-40 | 3680002004036800020040 | 355 mL in 1 BOTTLE (36800-200-40)Marketed from Aug 20, 2013 | |
| 36800-200-50 | 3680002005036800020050 | 2 BOTTLE in 1 PACKAGE (36800-200-50) / 355 mL in 1 BOTTLEMarketed from Aug 20, 2013 |
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 ZZZ Sleep
- Generic name (nonproprietary)
- diphenhydramine hcl
- Active ingredients
- Diphenhydramine hydrochloride — 50 mg/30mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Topco Associates LLCNDC labeler code 36800
- 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 36800-200_b2891495-9d6a-4173-bf1b-a94d7747370cSPL ID b2891495-9d6a-4173-bf1b-a94d7747370cSPL set ID 27225d04-6deb-436b-89ea-9842c487292eRxCUI 1248354, 1437306UNII 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
N436800020040followed by a unit qualifier and the quantityPackage 36800-0200-40. 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 the 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 36800-200
- What is NDC 36800-200?
- 36800-200 is the product NDC for Topcare ZZZ Sleep (diphenhydramine hcl), Diphenhydramine hydrochloride 50 mg/30mL solution, listed with the FDA by Topco Associates LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Topcare ZZZ Sleep (Diphenhydramine HCl).
- What is the active ingredient?
- Diphenhydramine hydrochloride.
- Who is the labeler?
- Topco Associates LLC, NDC labeler code 36800. 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 ZZZ Sleep?
- 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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