Over-the-counter drug · OTC MONOGRAPH DRUG
Extra Strength Pain Relief PM NDC 63941-095
acetaminophen and diphenhydramine hydrochloride · Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 · Tablet, Coated · Oral · VALU MERCHANDISERS COMPANY
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63941-095-02 | 6394100950263941009502 | 1 BOTTLE, PLASTIC in 1 CARTON (63941-095-02) / 50 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from Feb 1, 2010 | |
| 63941-095-03 | 6394100950363941009503 | 1 BOTTLE, PLASTIC in 1 CARTON (63941-095-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from Oct 4, 2011 | |
| 63941-095-09 | 6394100950963941009509 | 2 BOTTLE, PLASTIC in 1 CARTON (63941-095-09) / 100 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from Feb 3, 2012 |
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)
- Extra Strength Pain Relief PM
- Generic name (nonproprietary)
- acetaminophen and diphenhydramine hydrochloride
- Active ingredients
- Acetaminophen — 500 mg/1Diphenhydramine hydrochloride — 25 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- VALU MERCHANDISERS COMPANYNDC labeler code 63941
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 013
- Marketing start
- Marketing end
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 63941-095_45b0d446-7d54-c0c8-e063-6294a90a5230SPL ID 45b0d446-7d54-c0c8-e063-6294a90a5230SPL set ID f8820150-feec-4062-85bb-14525ddf691fRxCUI 1092189UNII 362O9ITL9D, TC2D6JAD40UPC 0070038201786
- 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
N463941009502followed by a unit qualifier and the quantityPackage 63941-0095-02. 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 63941-095
- What is NDC 63941-095?
- 63941-095 is the product NDC for Extra Strength Pain Relief PM, Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 tablet, coated, listed with the FDA by VALU MERCHANDISERS COMPANY. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Extra Strength Pain Relief PM (Acetaminophen and Diphenhydramine Hydrochloride).
- What is the active ingredient?
- Acetaminophen, Diphenhydramine hydrochloride.
- Who is the labeler?
- VALU MERCHANDISERS COMPANY, NDC labeler code 63941. 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 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 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 |
|---|---|---|---|---|
| Acetaminophen | Acetaminophen 500 mg/1 | Tablet, CoatedOral | COSTCO WHOLESALE CORPORATION | 63981-019 |
| Extra Strength Pain Releifacetaminophen | Acetaminophen 500 mg/1 | Tablet, Film coatedOral | Strategic Sourcing Services, LLC | 70677-1242 |
| Aspirin 81 mgaspirin | Aspirin 81 mg/1 | Tablet, Delayed releaseOral | H E B | 37808-600 |
| TYLENOL Extra Strengthacetaminophen | Acetaminophen 500 mg/1 | Tablet, Film coatedOral | Morning Star OTC | 53209-1001 |
| Extra Strength Pain Relieveracetaminophen tablets 500 mg | Acetaminophen 500 mg/1 | TabletOral | WALGREENS | 0363-0669 |
| Pain Relieveracetaminophen capsules 500mg (minis-red opaque) | Acetaminophen 500 mg/1 | Capsule, Liquid filledOral | Walgreens | 0363-6684 |
| Mommys Bliss Childrens Pain and Feveracetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Mom Enterprises, LLC. | 71444-793 |
| Childrens Pain and Feveracetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | CVS Pharmacy | 59779-126 |
| Good Neighbor Pharmacy childrens pain and feveracetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Amerisource Bergen | 46122-211 |
| Acetaminophen | Acetaminophen 160 mg/5mL | LiquidOral | A-S Medication Solutions | 50090-6059 |
| Members Mark Acetaminophenacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Sam's West Inc | 68196-606 |
| Mommys Bliss Infants Pain and Feveracetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Mom Enterprises, LLC. | 71444-893 |
| Thompson Extra Strength Non-Aspirinacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Thompson | 73408-174 |
| Aspirin 81 mg Low Doseaspirin | Aspirin 81 mg/1 | Tablet, Delayed releaseOral | CHAIN DRUG MARKETING ASSOCIATION, INC. | 83324-089 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | ASCLEMED USA INC. | 87063-222 |
| Pain Relief Aspirin Low Doseaspirin | Aspirin 81 mg/1 | Tablet, Delayed releaseOral | Rite Aid Corporation | 11822-0600 |
| equate pain and fever childrensacetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Wal-Mart Stores Inc | 49035-042 |
| Pain and Fever Childrensacetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | P & L Development, LLC | 49580-0282 |
| Dye Free Pain and Fever Childrensacetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Walgreens | 0363-0285 |
| Pain Reliever Extra Strengthacetaminophen | Acetaminophen 500 mg/1 | Tablet, CoatedOral | Walgreen Company | 0363-0519 |
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