Over-the-counter drug · OTC MONOGRAPH DRUG
Clear Choice Regular Strength Pain Reliever (Acetaminophen) NDC 53185-005
Acetaminophen 325 mg/1 · Tablet · Oral · Athlete's Needs, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53185-005-00 | 5318500050053185000500 | 100 TABLET in 1 BOTTLE (53185-005-00)Marketed from Jun 3, 2013 |
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)
- Clear Choice Regular Strength Pain Reliever
- Generic name (nonproprietary)
- acetaminophen
- Active ingredients
- Acetaminophen — 325 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Athlete's Needs, Inc.NDC labeler code 53185
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 013
- Marketing start
- Listing expires
- Identifiers
- Product ID 53185-005_07a99067-4ec1-49f8-8982-620e6efb78c5SPL ID 07a99067-4ec1-49f8-8982-620e6efb78c5SPL set ID d0d9fda5-5eba-4d51-b505-e93a2ae0bdd7RxCUI 313782UNII 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
N453185000500followed by a unit qualifier and the quantityPackage 53185-0005-00. 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 minor aches and pains associated with the common cold headache toothache muscular aches backache minor pain of arthritis premenstrual and menstrual cramps temporarily reduces fever
Excerpt only. Read the full label for complete information.
About NDC 53185-005
- What is NDC 53185-005?
- 53185-005 is the product NDC for Clear Choice Regular Strength Pain Reliever, Acetaminophen 325 mg/1 tablet, listed with the FDA by Athlete's Needs, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Clear Choice Regular Strength Pain Reliever (Acetaminophen).
- What is the active ingredient?
- Acetaminophen.
- Who is the labeler?
- Athlete's Needs, Inc., NDC labeler code 53185. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Clear Choice Regular Strength Pain Reliever?
- 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 |
|---|---|---|---|---|
| Headache Relief Extra Strengthacetaminophen, aspirin, caffeine | Acetaminophen 250 mg/1 + 2 more ingredients | TabletOral | TARGET Corporation | 11673-686 |
| Aspirin Low Dose Chewableaspirin | Aspirin 81 mg/1 | Tablet, ChewableOral | Better Living Brands, LLC | 21130-397 |
| TYLENOL Extra Strengthacetaminophen | Acetaminophen 500 mg/1 | Tablet, CoatedOral | Kenvue Brands LLC | 50580-490 |
| Medlineacetaminophen | Acetaminophen 325 mg/1 | TabletOral | Medline Industries, LP | 53329-194 |
| Acetaminophen Regular Strengthacetaminophen | Acetaminophen 325 mg/1 | TabletOral | Aurohealth LLC | 58602-748 |
| Aspirin | Aspirin 325 mg/1 | Tablet, CoatedOral | Marc Glassman, Inc. | 68998-018 |
| Mejoralitoacetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | OPMX Chula Vista | 69729-068 |
| Ed Apapacetaminophen | Acetaminophen 160 mg/5mL | LiquidOral | EDWARDS PHARMACEUTICALS, INC. | 0485-0057 |
| Childrens Acetaminophenacetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Advagen Pharma Limited | 72888-459 |
| pain and feveracetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Kroger Company | 30142-590 |
| equate pain relieveracetaminophen | Acetaminophen 500 mg/1 | TabletOral | Wal-Mart Stores Inc | 49035-308 |
| Tylenol Extra Strengthacetaminophen | Acetaminophen 500 mg/1 | Tablet, Film coatedOral | Kenvue Brands LLC | 50580-472 |
| Pain Reliefacetaminophen | Acetaminophen 500 mg/1 | Tablet, CoatedOral | DISCOUNT DRUG MART | 53943-092 |
| aspirin | Aspirin 81 mg/1 | Tablet, ChewableOral | Publix Super Markets Inc | 56062-274 |
| Acetaminophen Extra Strengthacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Aurohealth LLC | 58602-745 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3959 |
| Acetaminophen, Aspirin, Caffeine | Caffeine 65 mg/1 + 2 more ingredients | Tablet, Film coatedOral | CVS Pharmacy, Inc. | 69842-541 |
| Aspirin | Aspirin 325 mg/1 | Tablet, CoatedOral | FSA Store Inc. | 81522-018 |
| Aspirin | Aspirin 325 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-167 |
| Extra Strenght Headache Reliefacetaminophen, aspirin, caffeine | Acetaminophen 250 mg/1 + 2 more ingredients | TabletOral | Lil' Drug Store Products, Inc. | 29485-6538 |
Showing 20 of 40.