Over-the-counter drug · OTC MONOGRAPH DRUG
Extra Strength NiteTime Pain Relief NDC 0363-0714
acetaminophen 500 mg,diphenhydramine hydrochloride 25 mg tablet · Diphenhydramine hydrochloride 25 mg/1; Acetaminophen 500 mg/1 · Tablet · Oral · WALGREENS
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-0714-42 | 00363071442 | 1 BOTTLE in 1 CARTON (0363-0714-42) / 24 TABLET in 1 BOTTLEMarketed from Oct 12, 2021 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Extra Strength NiteTime Pain Relief
- Generic name (nonproprietary)
- acetaminophen 500 mg,diphenhydramine hydrochloride 25 mg tablet
- Active ingredients
- Diphenhydramine hydrochloride — 25 mg/1Acetaminophen — 500 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- WALGREENSNDC labeler code 0363
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 013
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0363-0714_3ac05a52-7cce-2bfb-e063-6394a90a134bSPL ID 3ac05a52-7cce-2bfb-e063-6394a90a134bSPL set ID c25c75c7-157f-1c0d-e053-2995a90a2e3cRxCUI 1092189UNII TC2D6JAD40, 362O9ITL9D
- 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
N400363071442followed by a unit qualifier and the quantityPackage 00363-0714-42. 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 temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Excerpt only. Read the full label for complete information.
About NDC 0363-0714
- What is NDC 0363-0714?
- 0363-0714 is the product NDC for Extra Strength NiteTime Pain Relief, Diphenhydramine hydrochloride 25 mg/1; Acetaminophen 500 mg/1 tablet, listed with the FDA by WALGREENS. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Extra Strength NiteTime Pain Relief (Acetaminophen 500 mg,Diphenhydramine Hydrochloride 25 mg Tablet).
- What is the active ingredient?
- Diphenhydramine hydrochloride, Acetaminophen.
- Who is the labeler?
- WALGREENS, NDC labeler code 0363. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Extra Strength NiteTime Pain Relief?
- 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 013
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 |
|---|---|---|---|---|
| 365 whole foods market acetaminophenacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Whole Foods Market, INC. | 42681-0025 |
| Acetaminophen | Acetaminophen 160 mg/5mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-0657 |
| Acetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | PAI Holdings, LLC dba PAI Pharma | 0121-0941 |
| Acetaminophen | Acetaminophen 160 mg/5mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-1047 |
| Acetaminophen | Acetaminophen 325 mg/10.15mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-1314 |
| Acetaminophen | Acetaminophen 325 mg/10.15mL | SuspensionOral | PAI Holdings, LLC dba PAI Pharma | 0121-1882 |
| Acetaminophen | Acetaminophen 650 mg/20.3mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-1971 |
| Acetaminophen | Acetaminophen 325 mg/10.15mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-2094 |
| Acetaminophen | Acetaminophen 650 mg/20.3mL | SuspensionOral | PAI Holdings, LLC dba PAI Pharma | 0121-2823 |
| Acetaminophen | Acetaminophen 650 mg/20.3mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-3141 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | WALGREENS | 0363-9538 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | WALGREEN CO. | 0363-9595 |
| Acetaminophen | Acetaminophen 160 mg/1 | TabletOral | WALGREEN CO. | 0363-9605 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | WALGREEN CO. | 0363-9798 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | Walgreens | 0363-9810 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | Rugby Laboratories | 0536-1172 |
| Acetaminophen | Acetaminophen 500 mg/1 | Tablet, CoatedOral | Rugby Laboratories | 0536-1292 |
| Acetaminophen | Acetaminophen 500 mg/1 | Tablet, Film coatedOral | Rugby Laboratories | 0536-1413 |
| Acetaminophen | Acetaminophen 325 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8608 |
| Acetaminophen | Acetaminophen 325 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8609 |
Showing 20 of 40.