Over-the-counter drug · ANDA
topcare all night pain relief pm NDC 36800-264
diphenhydramine hydrochloride, naproxen sodium · Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1 · Tablet, Film coated · Oral · Topco Associates LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36800-264-27 | 3680002642736800026427 | 1 BOTTLE in 1 CARTON (36800-264-27) / 80 TABLET, FILM COATED in 1 BOTTLEMarketed from Aug 12, 2019 | |
| 36800-264-60 | 3680002646036800026460 | 1 BOTTLE in 1 CARTON (36800-264-60) / 20 TABLET, FILM COATED in 1 BOTTLEMarketed from Aug 8, 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)
- topcare all night pain relief pm
- Generic name (nonproprietary)
- diphenhydramine hydrochloride, naproxen sodium
- Active ingredients
- Diphenhydramine hydrochloride — 25 mg/1Naproxen sodium — 220 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Topco Associates LLCNDC labeler code 36800
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208499
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 36800-264_32352610-bdfc-40f5-8d85-daa6fc9f7ae4SPL ID 32352610-bdfc-40f5-8d85-daa6fc9f7ae4SPL set ID a20f193e-4e64-400a-b605-df08026cb80bRxCUI 1550957UNII TC2D6JAD40, 9TN87S3A3C
- Pharmacologic class
- Histamine-1 Receptor Antagonist; Nonsteroidal Anti-inflammatory Drug
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
N436800026427followed by a unit qualifier and the quantityPackage 36800-0264-27. 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 when associated with minor aches and pains • helps you fall asleep and stay asleep
Excerpt only. Read the full label for complete information.
About NDC 36800-264
- What is NDC 36800-264?
- 36800-264 is the product NDC for topcare all night pain relief pm, Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1 tablet, film coated, 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 all night pain relief pm (Diphenhydramine hydrochloride, naproxen sodium).
- What is the active ingredient?
- Diphenhydramine hydrochloride, Naproxen sodium.
- 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 all night pain relief pm?
- 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 ANDA 208499
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 |
|---|---|---|---|---|
| All Night Pain Relief PMdiphenhydramine hydrochloride, naproxen sodium | Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Walgreen Company | 0363-2264 |
| basic care naproxen sodium pmdiphenhydramine hydrochloride, naproxen sodium | Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-310 |
| careone naproxen sodium pmdiphenhydramine hydrochloride, naproxen sodium | Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | American Sales Company | 41520-264 |
| dg health naproxen sodium pmdiphenhydramine hydrochloride, naproxen sodium | Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Dolgencorp Inc | 55910-858 |
| equaline naproxen sodium pmdiphenhydramine hydrochloride, naproxen sodium | Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | United Natural Foods, Inc. dba UNFI | 41163-593 |
| good sense naproxen sodiumdiphenhydramine hydrochloride, naproxen sodium | Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | L. Perrigo Company | 0113-8264 |
| Naproxen Sodium PMdiphenhydramine hydrochloride, naproxen sodium | Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Safeway | 21130-639 |
| naproxen sodium pmdiphenhydramine hydrochloride, naproxen sodium | Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1 | TabletOral | Kroger Company | 30142-753 |
| naproxen sodium pmdiphenhydramine hydrochloride, naproxen sodium | Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | H E B | 37808-264 |
| naproxen sodium pmdiphenhydramine hydrochloride, naproxen sodium | Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Meijer Distribution Inc | 41250-526 |
| up and up naproxen sodium pmdiphenhydramine hydrochloride, naproxen sodium | Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Target Corporation | 11673-687 |