Over-the-counter drug · OTC MONOGRAPH DRUG
Berkley and Jensen Pain Relief (Acetaminophen) NDC 68391-004
Acetaminophen 500 mg/1 · Tablet, Film coated · Oral · BJWC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68391-004-79 | 68391000479 | 400 TABLET, FILM COATED in 1 BOTTLE (68391-004-79)Marketed from Nov 30, 2015 |
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)
- Berkley and Jensen Pain Relief
- Generic name (nonproprietary)
- acetaminophen
- Active ingredients
- Acetaminophen — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- BJWCNDC labeler code 68391
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 013
- Marketing start
- Listing expires
- Identifiers
- Product ID 68391-004_c7b92375-0d31-4457-9517-8722eb8e2f7aSPL ID c7b92375-0d31-4457-9517-8722eb8e2f7aSPL set ID d3ee3341-93b8-487c-921e-2892d213efbbRxCUI 198440UNII 362O9ITL9D
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
N468391000479followed by a unit qualifier and the quantityPackage 68391-0004-79. 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 • temporarily relieves minor aches and pains due to: • the common cold • minor pain of arthritis • headache • backache • toothache • muscular aches • premenstrual and menstrual cramps • temporarily reduces fever
Excerpt only. Read the full label for complete information.
About NDC 68391-004
- What is NDC 68391-004?
- 68391-004 is the product NDC for Berkley and Jensen Pain Relief (acetaminophen), Acetaminophen 500 mg/1 tablet, film coated, listed with the FDA by BJWC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Berkley and Jensen Pain Relief (Acetaminophen).
- What is the active ingredient?
- Acetaminophen.
- Who is the labeler?
- BJWC, NDC labeler code 68391. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Berkley and Jensen 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 |
|---|---|---|---|---|
| Best Choice Effervescent Pain Reliever 36aspirin | Aspirin 325 mg/1 | Tablet, EffervescentOral | VALU MERCHANDISERS COMPANY | 63941-241 |
| Aspirin Packsaspirin | Aspirin 325 mg/1 | Tablet, Film coatedOral | Sina Health Inc | 70385-2006 |
| Back and Body Extra Strengthaspirin, caffeine | Aspirin 500 mg/1; Caffeine 32.5 mg/1 | Tablet, Film coatedOral | Cardinal Health 110, LLC. DBA Leader | 70000-0127 |
| foster and thrive aspirinaspirin | Aspirin 81 mg/1 | Tablet, ChewableOral | Strategic Sourcing Services LLC | 70677-1134 |
| Medique Pain Offacetaminophen, aspirin, caffeine | Caffeine 65 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Unifirst First Aid Corporation | 47682-238 |
| Acetaminophen Extra Strengthacetaminophen | Acetaminophen 500 mg/1 | Tablet, Film coatedOral | Wal-Mart Stores Inc | 49035-175 |
| Low Dose Aspirinaspirin | Aspirin 81 mg/1 | Tablet, CoatedOral | A-S Medication Solutions | 50090-4830 |
| Childrens Pain Relief | Acetaminophen 160 mg/5mL | LiquidOral | Allegiant Health | 69168-455 |
| Aspirin Low Doseaspirin | Aspirin 81 mg/1 | Tablet, CoatedOral | MAJOR PHARMACEUTICALS | 0904-6783 |
| equaline acetaminophenacetaminophen | Acetaminophen 500 mg/1 | TabletOral | United Natural Foods, Inc. dba UNFI | 41163-363 |
| Chewable Aspirinaspirin | Aspirin 81 mg/1 | Tablet, ChewableOral | HARRIS TEETER | 72036-205 |
| Pain Relief PM Extra Strengthacetaminophen and diphenhydramine hydrochloride | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | Chain Drug Marketing Association | 63868-325 |
| Excedrin Extra Strength and Excedrin Tension Headacheacetaminophen, aspirin (nsaid), and caffeine | — | Kit | Haleon US Holdings LLC | 0067-8151 |
| Enteric Coated Aspirin Regular Strengthaspirin | Aspirin 325 mg/1 | Tablet, Delayed releaseOral | Safeway | 21130-081 |
| Headache Relief Extra Strengthacetaminophen, aspirin, caffeine | Acetaminophen 250 mg/1 + 2 more ingredients | TabletOral | H E B | 37808-586 |
| DrKids Childrens Pain and Feveracetaminophen 80mg/piece | Acetaminophen 80 mg/1 | Bar, ChewableOral | CalmCo LLC | 73282-2480 |
| CAREALL Non-Aspirin PM Extra Strengthacetaminophen, diphenhydramine hcl | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | TabletOral | New World Imports, Inc | 51824-069 |
| dg health pain reliefacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Dolgencorp Inc | 55910-661 |
| Extra Strength Acetaminophenacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4065 |
| Aspirin 81mg Dye-Freeaspirin 81mg | Aspirin 81 mg/1 | Tablet, Film coatedOral | Allegiant Health | 69168-457 |
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