Over-the-counter drug · OTC MONOGRAPH NOT FINAL
Childrens Tukol Acetaminophen Fever Reducer Pain Reducer (Acetaminophen) NDC 50066-525
Acetaminophen 160 mg/5mL · Liquid · Oral · Genomma Lab USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50066-525-24 | 5006605252450066052524 | 118 mL in 1 BOTTLE (50066-525-24)Marketed from May 3, 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)
- Childrens Tukol Acetaminophen Fever Reducer Pain Reducer
- Generic name (nonproprietary)
- acetaminophen
- Active ingredients
- Acetaminophen — 160 mg/5mL
- Dosage form
- Liquid
- Route
- Oral
- Labeler
- Genomma Lab USA, Inc.NDC labeler code 50066
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph (not final)Application part343
- Marketing start
- Listing expires
- Identifiers
- Product ID 50066-525_abbc3017-0f3f-4c00-aa6f-c5786b17b423SPL ID abbc3017-0f3f-4c00-aa6f-c5786b17b423SPL set ID 0540111a-fcde-492d-9ed5-bbd714b2acf0RxCUI 307668UNII 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
N450066052524followed by a unit qualifier and the quantityPackage 50066-0525-24. 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 reduces fever relieves minor aches and pains due to: the common cold flu headache sore throat toothache
Excerpt only. Read the full label for complete information.
About NDC 50066-525
- What is NDC 50066-525?
- 50066-525 is the product NDC for Childrens Tukol Acetaminophen Fever Reducer Pain Reducer, Acetaminophen 160 mg/5mL liquid, listed with the FDA by Genomma Lab USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Childrens Tukol Acetaminophen Fever Reducer Pain Reducer (Acetaminophen).
- What is the active ingredient?
- Acetaminophen.
- Who is the labeler?
- Genomma Lab USA, Inc., NDC labeler code 50066. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Childrens Tukol Acetaminophen Fever Reducer Pain Reducer?
- 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 |
| CounterAct PMacetaminophen and diphenhydramine | Diphenhydramine hydrochloride 25 mg/1; Acetaminophen 500 mg/1 | TabletOral | Melaleuca, Inc. | 54473-304 |
| 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 |
| Apapacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Richmond Pharmaceuticals, Inc. | 54738-040 |
Showing 20 of 37.