Over-the-counter drug · OTC MONOGRAPH DRUG
Extra Strength No-Pain (Acetaminophen) NDC 71309-001
Acetaminophen 500 mg/1 · Tablet · Oral · Safrel Pharmaceuticals, LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71309-001-05 | 71309000105 | 500 TABLET in 1 BOTTLE (71309-001-05)Marketed from Jul 31, 2017 | |
| 71309-001-40 | 71309000140 | 1 BOTTLE in 1 CARTON (71309-001-40) / 40 TABLET in 1 BOTTLEMarketed from Jul 31, 2017 |
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 No-Pain
- Generic name (nonproprietary)
- acetaminophen
- Active ingredients
- Acetaminophen — 500 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Safrel Pharmaceuticals, LLC.NDC labeler code 71309
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 013
- Marketing start
- Listing expires
- Identifiers
- Product ID 71309-001_3371e8dc-ae55-9a65-e063-6394a90aeaacSPL ID 3371e8dc-ae55-9a65-e063-6394a90aeaacSPL set ID 873f01dd-0701-5fd3-e053-2a95a90a6463RxCUI 198440UNII 362O9ITL9DUPC 0371309001051
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
N471309000105followed by a unit qualifier and the quantityPackage 71309-0001-05. 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 temporary relieves minor aches and pains due to the common cold headache backache toothache muscular aches premenstrual and menstrual cramps and temporarily reduces fever
Excerpt only. Read the full label for complete information.
About NDC 71309-001
- What is NDC 71309-001?
- 71309-001 is the product NDC for Extra Strength No-Pain (acetaminophen), Acetaminophen 500 mg/1 tablet, listed with the FDA by Safrel Pharmaceuticals, LLC.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Extra Strength No-Pain (Acetaminophen).
- What is the active ingredient?
- Acetaminophen.
- Who is the labeler?
- Safrel Pharmaceuticals, LLC., NDC labeler code 71309. 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 No-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 |
|---|---|---|---|---|
| 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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