Over-the-counter drug · OTC MONOGRAPH NOT FINAL
CounterAct PM (Acetaminophen and diphenhydramine) NDC 54473-304
Diphenhydramine hydrochloride 25 mg/1; Acetaminophen 500 mg/1 · Tablet · Oral · Melaleuca, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54473-304-01 | 5447303040154473030401 | 1 BOTTLE in 1 BOX (54473-304-01) / 50 TABLET in 1 BOTTLE (54473-304-50)Marketed from May 2, 2016 |
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 PMSuffix: PM
- Generic name (nonproprietary)
- acetaminophen and diphenhydramine
- Active ingredients
- Diphenhydramine hydrochloride — 25 mg/1Acetaminophen — 500 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Melaleuca, Inc.NDC labeler code 54473
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph (not final)Application part343
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 54473-304_7fbf2b51-9097-0a1f-e053-2991aa0a6aa1SPL ID 7fbf2b51-9097-0a1f-e053-2991aa0a6aa1SPL set ID 7f9a0062-0e86-1deb-e053-2a91aa0a9188RxCUI 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
N454473030401followed by a unit qualifier and the quantityPackage 54473-0304-01. 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 occassional headaches, minor aches, and pains with accompanying sleeplessness
Excerpt only. Read the full label for complete information.
About NDC 54473-304
- What is NDC 54473-304?
- 54473-304 is the product NDC for CounterAct PM, Diphenhydramine hydrochloride 25 mg/1; Acetaminophen 500 mg/1 tablet, 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 PM (Acetaminophen and Diphenhydramine).
- What is the active ingredient?
- Diphenhydramine hydrochloride, 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 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 part343
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 |
|---|---|---|---|---|
| aspirin low dose enteric coatedaspirin | Aspirin 81 mg/1 | Tablet, CoatedOral | Time-Cap Labs, Inc | 49483-387 |
| aspirin low dose enteric coatedaspirin | Aspirin 81 mg/1 | TabletOral | Time-Cap Labs, Inc | 49483-390 |
| Acetaminophen Capletsacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Breeden Brothers, LLC | 70729-001 |
| Acetaminophen Capletsacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Breeden Brothers, LLC | 70729-175 |
| Geritrex Aspirinaspirin | Aspirin 325 mg/1 | Tablet, CoatedOral | Geritrex LLC | 54162-940 |
| Pain Relief PMacetaminophen pm | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | TabletOral | Velocity Pharma | 76168-119 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | Velocity Pharma LLC | 76168-120 |
| Acetaminophen | Acetaminophen 325 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-238 |
| Broncochem Expectorant IIacetaminophen-chlorpheniramine maleate-dextromethorphan hbr-guaifenesin-phenylephrine hcl | Acetaminophen 250 mg/10mL + 4 more ingredients | SyrupOral | LABORATORIO MAGNACHEM INTERNATIONAL SRL | 65131-116 |
| Aspirin | Aspirin 325 mg/1 | TabletOral | Advance Pharmaceutical Inc. | 17714-010 |
| Aspirin | Aspirin 325 mg/1 | TabletOral | Advance Pharmaceutical Inc. | 17714-011 |
| Acetaminophen | Acetaminophen 325 mg/1 | TabletOral | Advance Pharmaceutical Inc. | 17714-012 |
| Apapacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Advance Pharmaceutical Inc. | 17714-013 |
| Apapacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Advance Pharmaceutical Inc. | 17714-014 |
| Aspirin | Aspirin 81 mg/1 | TabletOral | Advance Pharmaceutical Inc. | 17714-121 |
| Extra Strength Acetaminophenacetaminophen | Acetaminophen 500 mg/1 | Tablet, Film coatedOral | PuraCap Pharmaceutical LLC | 51013-320 |
| Doans Extra Strengthmagnesium salicylate | Magnesium salicylate 580 mg/1 | TabletOral | Dr. Reddy's Laboratories Inc. | 55741-224 |
| Extra Strength Acetaminophenacetaminophen | Acetaminophen 500 mg/1 | Tablet, Film coatedOral | CVS PHARMACY, INC. | 69842-390 |
| Childrens Tukol Acetaminophen Fever Reducer Pain Reduceracetaminophen | Acetaminophen 160 mg/5mL | LiquidOral | Genomma Lab USA, Inc. | 50066-525 |
| Apapacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Richmond Pharmaceuticals, Inc. | 54738-040 |
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