Over-the-counter drug · OTC MONOGRAPH DRUG
Children Acetaminophen (Acetaminophen) NDC 82568-0008
Acetaminophen 160 mg/5mL · Liquid · Oral · AARNA USA INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82568-0008-4 | 8256800080482568000804 | 1 BOTTLE in 1 PACKAGE (82568-0008-4) / 118 mL in 1 BOTTLEMarketed from Feb 18, 2025 | |
| 82568-0008-6 | 8256800080682568000806 | 473 mL in 1 BOTTLE (82568-0008-6)Marketed from Feb 18, 2025 | |
| 82568-0008-8 | 8256800080882568000808 | 1 BOTTLE in 1 PACKAGE (82568-0008-8) / 236 mL in 1 BOTTLEMarketed from Feb 18, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Children Acetaminophen
- Generic name (nonproprietary)
- acetaminophen
- Active ingredients
- Acetaminophen — 160 mg/5mL
- Dosage form
- Liquid
- Route
- Oral
- Labeler
- AARNA USA INC.NDC labeler code 82568
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 013
- Marketing start
- Listing expires
- Identifiers
- Product ID 82568-0008_354289e0-a1d5-590d-e063-6394a90a2ec3SPL ID 354289e0-a1d5-590d-e063-6394a90a2ec3SPL set ID 25bcb9d5-f388-4ae7-8037-970ffe8d17f0RxCUI 307668UNII 362O9ITL9DUPC 0382568000884
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
N482568000804followed by a unit qualifier and the quantityPackage 82568-0008-04. 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 82568-0008
- What is NDC 82568-0008?
- 82568-0008 is the product NDC for Children Acetaminophen (acetaminophen), Acetaminophen 160 mg/5mL liquid, listed with the FDA by AARNA USA INC.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Children Acetaminophen (Acetaminophen).
- What is the active ingredient?
- Acetaminophen.
- Who is the labeler?
- AARNA USA INC., NDC labeler code 82568. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Children Acetaminophen?
- 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 |
|---|---|---|---|---|
| Acetaminophen | Acetaminophen 500 mg/1 | Tablet, CoatedOral | COSTCO WHOLESALE CORPORATION | 63981-019 |
| Extra Strength Pain Releifacetaminophen | Acetaminophen 500 mg/1 | Tablet, Film coatedOral | Strategic Sourcing Services, LLC | 70677-1242 |
| Aspirin 81 mgaspirin | Aspirin 81 mg/1 | Tablet, Delayed releaseOral | H E B | 37808-600 |
| TYLENOL Extra Strengthacetaminophen | Acetaminophen 500 mg/1 | Tablet, Film coatedOral | Morning Star OTC | 53209-1001 |
| Extra Strength Pain Relieveracetaminophen tablets 500 mg | Acetaminophen 500 mg/1 | TabletOral | WALGREENS | 0363-0669 |
| Pain Relieveracetaminophen capsules 500mg (minis-red opaque) | Acetaminophen 500 mg/1 | Capsule, Liquid filledOral | Walgreens | 0363-6684 |
| Mommys Bliss Childrens Pain and Feveracetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Mom Enterprises, LLC. | 71444-793 |
| Childrens Pain and Feveracetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | CVS Pharmacy | 59779-126 |
| Good Neighbor Pharmacy childrens pain and feveracetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Amerisource Bergen | 46122-211 |
| Acetaminophen | Acetaminophen 160 mg/5mL | LiquidOral | A-S Medication Solutions | 50090-6059 |
| Members Mark Acetaminophenacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Sam's West Inc | 68196-606 |
| Mommys Bliss Infants Pain and Feveracetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Mom Enterprises, LLC. | 71444-893 |
| Thompson Extra Strength Non-Aspirinacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Thompson | 73408-174 |
| Aspirin 81 mg Low Doseaspirin | Aspirin 81 mg/1 | Tablet, Delayed releaseOral | CHAIN DRUG MARKETING ASSOCIATION, INC. | 83324-089 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | ASCLEMED USA INC. | 87063-222 |
| Pain Relief Aspirin Low Doseaspirin | Aspirin 81 mg/1 | Tablet, Delayed releaseOral | Rite Aid Corporation | 11822-0600 |
| equate pain and fever childrensacetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Wal-Mart Stores Inc | 49035-042 |
| Pain and Fever Childrensacetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | P & L Development, LLC | 49580-0282 |
| Dye Free Pain and Fever Childrensacetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Walgreens | 0363-0285 |
| Pain Reliever Extra Strengthacetaminophen | Acetaminophen 500 mg/1 | Tablet, CoatedOral | Walgreen Company | 0363-0519 |
Showing 20 of 40.