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 |
|---|---|---|---|---|
| Childrens Acetaminophenacetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Grocery Outlet, Inc. | 85828-922 |
| Pain Relief Regular Strengthacetaminophen | Acetaminophen 325 mg/1 | TabletOral | CHAIN DRUG MARKETING ASSOCIATION INC | 83324-076 |
| equate pain and fever childrensacetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Wal-Mart Stores Inc | 49035-042 |
| good neighbor pharmacy childrens pain and feveracetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Amerisource Bergen | 46122-210 |
| Aspirin | Aspirin 81 mg/1 | Tablet, Delayed releaseOral | GOODSENSE | 50804-880 |
| Tylenol PM Extra Strengthacetaminophen and diphenhydramine hydrochloride | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Morning Star OTC | 53209-1002 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-7897 |
| Headache Formula Extra Strengthacetaminophen, aspirin, caffeine | Acetaminophen 250 mg/1 + 2 more ingredients | Tablet, Film coatedOral | ARMY AND AIR FORCE EXCHANGE SERVICE | 55301-334 |
| childrens pain and feveracetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Walgreen Company | 0363-1239 |
| Tylenol PMacetaminophen, diphenhydramine hydrochloride | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Savings Distributors LLC | 73097-013 |
| Alka-Seltzer Originalanhydrous citric acid, aspirin, and sodium bicarbonate | Anhydrous citric acid 1000 mg/1 + 2 more ingredients | Tablet, EffervescentOral | Bayer HealthCare LLC. | 0280-4000 |
| Aspirin Low Doseaspirin | Aspirin 81 mg/1 | Tablet, Delayed releaseOral | Strategic Sourcing Services LLC | 70677-1260 |
| basic care infants pain and feveracetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Amazon.com Services LLC | 72288-946 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | Sportpharm LLC | 85766-223 |
| Pain Relief Aspirin Low Doseaspirin | Aspirin 81 mg/1 | Tablet, Delayed releaseOral | Rite Aid Corporation | 11822-0600 |
| Equaline Effervescent Antacid and Pain Reliefaspirin, citric acid, sodium bicarbonate | Aspirin 325 mg/1 + 2 more ingredients | Tablet, EffervescentOral | United Natural Foods, Inc. dba UNFI | 41163-421 |
| Night Time Severe Cold and Cough Reliefacetaminophen, diphenhydramine hcl, phenylephrine hcl | Acetaminophen 325 mg/15mL + 2 more ingredients | LiquidOral | Chain Drug Consortium, LLC | 68016-154 |
| Tension Headache Relief | Acetaminophen 500 mg/1; Caffeine 65 mg/1 | Capsule, CoatedOral | Allegiant Health | 69168-001 |
| Childrens Acetaminophenacetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Proficient Rx LP | 71205-263 |
| Chewable Aspirinaspirin | Aspirin 81 mg/1 | Tablet, ChewableOral | Chain Drug Marketing Association, Inc. | 83324-075 |
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