Over-the-counter drug · OTC MONOGRAPH DRUG
Pain Relief (Acetaminophen) NDC 36800-591
Acetaminophen 500 mg/1 · Tablet, Coated · Oral · Topco Associates, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36800-591-05 | 36800059105 | 400 TABLET, COATED in 1 BOTTLE, PLASTIC (36800-591-05)Marketed from Dec 23, 2019 | |
| 36800-591-08 | 36800059108 | 1 BOTTLE, PLASTIC in 1 CARTON (36800-591-08) / 24 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from Dec 23, 2019 | |
| 36800-591-12 | 36800059112 | 1 BOTTLE, PLASTIC in 1 CARTON (36800-591-12) / 100 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from Dec 23, 2019 | |
| 36800-591-20 | 36800059120 | 1 BOTTLE, PLASTIC in 1 CARTON (36800-591-20) / 225 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from Dec 23, 2019 |
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)
- Pain Relief
- Generic name (nonproprietary)
- acetaminophen
- Active ingredients
- Acetaminophen — 500 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Topco Associates, LLCNDC labeler code 36800
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 013
- Marketing start
- Listing expires
- Identifiers
- Product ID 36800-591_2fef8293-e904-4b4a-a16a-8379d3dd1c14SPL ID 2fef8293-e904-4b4a-a16a-8379d3dd1c14SPL set ID 2e31fe65-5f50-455b-99fa-c72879f43545RxCUI 198440UNII 362O9ITL9DUPC 0036800199910
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
N436800059105followed by a unit qualifier and the quantityPackage 36800-0591-05. 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: headache the common cold backache minor pain from arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever
Excerpt only. Read the full label for complete information.
About NDC 36800-591
- What is NDC 36800-591?
- 36800-591 is the product NDC for Pain Relief (acetaminophen), Acetaminophen 500 mg/1 tablet, coated, listed with the FDA by Topco Associates, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pain Relief (Acetaminophen).
- What is the active ingredient?
- Acetaminophen.
- Who is the labeler?
- Topco Associates, LLC, NDC labeler code 36800. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pain Relief?
- 62 other product NDCs are listed under this name. See all Pain Relief NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Pain Relief products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Pain Reliefacetaminophen | Acetaminophen 325 mg/1 | TabletOral | Shield Pharmaceuticals Corp. | 83059-0160 | — |
| Pain Reliefmenthol spray | Menthol 76.6 mg/mL | SprayTopical | Owell Naturals Brand, LLC | 83570-003 | 83570-0003-02 |
| Pain Reliefarnica montana, belladonna, gelsemium sempervirens, gnaphalium polycephalum, magnesia phosphorica, sanguinaria canadensis, salix alba | Arnica montana whole 6 [hp_X]/1 + 6 more ingredients | TabletOral | NaturalCare | 70163-0022 | 70163-0022-01 |
| pain reliefacetaminophen | Acetaminophen 500 mg/1 | Tablet, Film coatedOral | HyVee Inc | 42507-813 | 42507-0813-78 |
| Pain Reliefmenthol | Menthol 10.5 g/100mL | SprayTopical | Trifecta Pharmaceuticals USA, LLC. | 69396-175 | 69396-0175-03 |
| Pain Reliefacetaminophen | Acetaminophen 500 mg/1 | TabletOral | HYVEE INC | 42507-103 | 42507-0103-04 |
| Pain Reliefacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | HYVEE INC | 42507-303 | 42507-0303-03 |
| Pain Reliefacetaminophen | Acetaminophen 500 mg/1 | Tablet, CoatedOral | HYVEE INC | 42507-404 | 42507-0404-09 |
| Pain Reliefacetaminophen | Acetaminophen 500 mg/1 | Tablet, CoatedOral | HYVEE INC | 42507-592 | 42507-0592-03 |
| Pain Relieflidocaine | Lidocaine .04 g/g | PatchTopical | Shanghai Chuangshi Medical Technology (Group) Co., Ltd. | 73557-189 | 73557-0189-30 |
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 |
|---|---|---|---|---|
| 365 whole foods market acetaminophenacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Whole Foods Market, INC. | 42681-0025 |
| Acetaminophen | Acetaminophen 160 mg/5mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-0657 |
| Acetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | PAI Holdings, LLC dba PAI Pharma | 0121-0941 |
| Acetaminophen | Acetaminophen 160 mg/5mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-1047 |
| Acetaminophen | Acetaminophen 325 mg/10.15mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-1314 |
| Acetaminophen | Acetaminophen 325 mg/10.15mL | SuspensionOral | PAI Holdings, LLC dba PAI Pharma | 0121-1882 |
| Acetaminophen | Acetaminophen 650 mg/20.3mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-1971 |
| Acetaminophen | Acetaminophen 325 mg/10.15mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-2094 |
| Acetaminophen | Acetaminophen 650 mg/20.3mL | SuspensionOral | PAI Holdings, LLC dba PAI Pharma | 0121-2823 |
| Acetaminophen | Acetaminophen 650 mg/20.3mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-3141 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | WALGREENS | 0363-9538 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | WALGREEN CO. | 0363-9595 |
| Acetaminophen | Acetaminophen 160 mg/1 | TabletOral | WALGREEN CO. | 0363-9605 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | WALGREEN CO. | 0363-9798 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | Walgreens | 0363-9810 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | Rugby Laboratories | 0536-1172 |
| Acetaminophen | Acetaminophen 500 mg/1 | Tablet, CoatedOral | Rugby Laboratories | 0536-1292 |
| Acetaminophen | Acetaminophen 500 mg/1 | Tablet, Film coatedOral | Rugby Laboratories | 0536-1413 |
| Acetaminophen | Acetaminophen 325 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8608 |
| Acetaminophen | Acetaminophen 325 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8609 |
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