Over-the-counter drug · OTC MONOGRAPH DRUG
CounterAct Pain (Acetaminophen) NDC 54473-305
Acetaminophen 500 mg/1 · Tablet, Film coated · Oral · Melaleuca, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54473-305-50 | 54473030550 | 1 BOTTLE in 1 BOX (54473-305-50) / 50 TABLET, FILM COATED in 1 BOTTLEMarketed from Jan 1, 2018 |
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)
- CounterAct PainSuffix: Pain
- Generic name (nonproprietary)
- acetaminophen
- Active ingredients
- Acetaminophen — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Melaleuca, Inc.NDC labeler code 54473
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 013
- Marketing start
- Listing expires
- Identifiers
- Product ID 54473-305_30ce656f-cab7-9520-e063-6294a90a43ffSPL ID 30ce656f-cab7-9520-e063-6294a90a43ffSPL set ID 7faf76b4-7f25-377d-e053-2a91aa0a19d4RxCUI 198440, 1100005UNII 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
N454473030550followed by a unit qualifier and the quantityPackage 54473-0305-50. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Uses for the temporary relief of minor aches and pains due to: headache the common cold backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever
Excerpt only. Read the full label for complete information.
About NDC 54473-305
- What is NDC 54473-305?
- 54473-305 is the product NDC for CounterAct Pain (acetaminophen), Acetaminophen 500 mg/1 tablet, film coated, listed with the FDA by Melaleuca, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- CounterAct Pain (Acetaminophen).
- What is the active ingredient?
- Acetaminophen.
- Who is the labeler?
- Melaleuca, Inc., NDC labeler code 54473. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for CounterAct Pain?
- 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 |
|---|---|---|---|---|
| Xesso Neobenzocaine | Benzocaine 5 g/100mL | SprayOral, Topical | PREMIUM NATURAL COSMETICS INC | 81777-106 |
| MAX relief junior Grapechildrens acetaminophen | Acetaminophen 160 mg/5mL | LiquidOral | ATLANTIC BIOLOGICALS CORP. | 17856-1123 |
| equate aspirinaspirin | Aspirin 81 mg/1 | Tablet, ChewableOral | Wal-Mart Stores Inc | 49035-467 |
| Acetaminophen | Acetaminophen 325 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-7899 |
| Acetaminophen | Acetaminophen 325 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-346 |
| Bayer Rapid Reliefaspirin/caffeine oral powder | Caffeine 65 mg/1; Aspirin 650 mg/1 | PowderOral | Bayer HealthCare LLC. | 0280-0103 |
| Acetaminophen | Acetaminophen 650 mg/20.3mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-3141 |
| Headache Reliefacetaminophen, aspirin, caffeine | Acetaminophen 250 mg/1 + 2 more ingredients | Tablet, Film coatedOral | DOLGENCORP, LLC | 55910-345 |
| Aspirin Enteric Coated, Regular Strengthaspirin | Aspirin 325 mg/1 | Tablet, Delayed releaseOral | Walgreen Company | 0363-0227 |
| Aspirin | Aspirin 325 mg/1 | Tablet, CoatedOral | CHAIN DRUG MARKETING ASSOCIATION, INC. | 83324-205 |
| MAX relief junior Grapechildrens acetaminophen | Acetaminophen 160 mg/5mL | LiquidOral | ATLANTIC BIOLOGICALS CORP. | 17856-1122 |
| Pain Relief Extra Strengthacetaminophen | Acetaminophen 500 mg/1 | Tablet, CoatedOral | H E B | 37808-195 |
| childrens mapapacetaminophen | Acetaminophen 160 mg/1 | Tablet, ChewableOral | Proficient Rx LP | 71205-322 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | WALMART INC | 79903-296 |
| Extra Strength Pain Relieveracetaminophen 500 mg | Acetaminophen 500 mg/1 | TabletOral | Lil' Drug Store Products, Inc. | 29485-9281 |
| 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 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | Family Dollar, Inc. | 55319-751 |
| Alka-Seltzerbuffered aspirin | Aspirin 325 mg/1 | Tablet, EffervescentOral | Lil' Drug Store Products, Inc. | 66715-5206 |
| Extra Strength Pain Reliefacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8786 |
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