Over-the-counter drug · OTC MONOGRAPH DRUG
Childrens Ibuprofen Oral Suspension (Ibuprofen) NDC 69618-078
Ibuprofen 100 mg/5mL · Suspension · Oral · Reliable 1 Laboratories LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)69618-078Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69618-0078Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69618-078-54 | 6961800785469618007854 | 1 BOTTLE in 1 CARTON (69618-078-54) / 118 mL in 1 BOTTLEMarketed from Dec 2, 2024 |
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 Ibuprofen Oral Suspension
- Generic name (nonproprietary)
- ibuprofen
- Active ingredients
- Ibuprofen — 100 mg/5mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- Reliable 1 Laboratories LLCNDC labeler code 69618
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 012
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 69618-078_2bc7eda7-d97a-e728-e063-6394a90a091eSPL ID 2bc7eda7-d97a-e728-e063-6394a90a091eSPL set ID 28dd9baa-43bd-b60a-e063-6394a90a8cf7RxCUI 197803UNII WK2XYI10QM
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug
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
N469618007854followed by a unit qualifier and the quantityPackage 69618-0078-54. 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)
Directions this product does not contain directions or complete warnings for adult use do not give more than directed shake well before using mL = milliliter find right dose on chart. If possible, use weight to dose; otherwise use age. use only enclosed dosing cup. Do not use any other dosing device. if needed, repeat dose every 6-8 hours do not use more than 4 times a day replace original bottle cap to maintain child resistance
Excerpt only. Read the full label for complete information.
About NDC 69618-078
- What is NDC 69618-078?
- 69618-078 is the product NDC for Childrens Ibuprofen Oral Suspension, Ibuprofen 100 mg/5mL suspension, listed with the FDA by Reliable 1 Laboratories LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Childrens Ibuprofen Oral Suspension (Ibuprofen).
- What is the active ingredient?
- Ibuprofen.
- Who is the labeler?
- Reliable 1 Laboratories LLC, NDC labeler code 69618. 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 Ibuprofen Oral Suspension?
- 9 other product NDCs are listed under this name. See all Childrens Ibuprofen Oral Suspension NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Childrens Ibuprofen Oral Suspension products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Childrens Ibuprofen Oral Suspensionibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | PAI Holdings, LLC dba PAI Pharma | 0121-0833 | 00121-0833-0000121-0833-40 |
| Childrens Ibuprofen Oral Suspensionibuprofen | Ibuprofen 200 mg/10mL | SuspensionOral | PAI Holdings, LLC dba PAI Pharma | 0121-1666 | 00121-1666-0000121-1666-40 |
| Childrens Ibuprofen Oral Suspensionibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Chain Drug Marketing Association, Inc. | 63868-796 | 63868-0796-04 |
| Childrens Ibuprofen Oral Suspensionibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | AptaPharma Inc. | 76281-119 | 76281-0119-24 |
| Childrens Ibuprofen Oral Suspensionibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Marc Glassman, Inc. | 68998-320 | 68998-0320-24 |
| Childrens Ibuprofen Oral Suspensionibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | DEMOULAS SUPERMARKETS INC. | 53942-119 | 53942-0119-24 |
| Childrens Ibuprofen Oral Suspensionibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Discount Drug Mart | 53943-119 | 53943-0119-24 |
| Childrens Ibuprofen Oral Suspensionibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Pharmaceutical Associates, Inc. | 0121-0914 | 00121-0914-00 |
| Childrens Ibuprofen Oral Suspensionibuprofen | Ibuprofen 100 mg/10mL | SuspensionOral | Pharmaceutical Associates, Inc. | 0121-1828 | 00121-1828-00 |
Other NDCs under M 012
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 |
|---|---|---|---|---|
| Cough Reliefdextromethorphan hydrobromide | Dextromethorphan hydrobromide 15 mg/1 | Capsule, Liquid filledOral | Advanced Rx LLC | 80513-311 |
| TARGET Multi Symptom Flu Reliefacetaminophen, dextromethorphan hbr, and acetaminophen, chlorpheniramine maleate, dextromethorphan hbr | — | Kit | TARGET CORPORATION | 82442-559 |
| Geri-Dryl allergy reliefdiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | VerityRx | 83939-0683 |
| Multi Symptom Cold and Multi Symptom Nighttime Cold Childrensdextromethorphan hbr, guaifenesin, phenylephrine hci, acetaminophen, diphenhydramine hci, phenylephrine hci | — | Kit | TARGET Corporation | 11673-420 |
| Welmedix HomeCare PRO Extra Strength Rapid Rash Reliefpetrolatum, zinc oxide | Petrolatum 49 g/100g; Zinc oxide 15 g/100g | CreamTopical | Welmedix LLC | 24330-410 |
| topcare nite time cold and fluacetaminophen, dextromethorphan hbr, doxylamine succinate | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Topco Associates LLC | 36800-143 |
| Allergy Childrensdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | LiquidOral | H E B | 37808-012 |
| Mucus Relief Cough Childrensdextromethorphan hbr, guaifensin | Dextromethorphan hydrobromide 5 mg/5mL; Guaifenesin 100 mg/5mL | LiquidOral | H E B | 37808-594 |
| Sunmark Chest Congestion Relief DM DMdextromethorphan hydrobromide / guaifenesin | Dextromethorphan hydrobromide 20 mg/1; Guaifenesin 400 mg/1 | TabletOral | Strategic Sourcing Services LLC | 49348-728 |
| Dual Action Honey Lemon Cough Suppressant Oral Anestheticmenthol | Menthol 8.3 mg/1 | LozengeOral | Ricola Ag | 54305-323 |
| Discount drug mart Extra Moisturizingoxymetazoline hydrochloride | Oxymetazoline hydrochloride .05 g/100mL | SprayNasal | DISCOUNT DRUG MART | 53943-720 |
| Mucus Reliefguaifenesin | Guaifenesin 400 mg/1 | TabletOral | Geri-Care Pharmaceuticals, Corp | 57896-714 |
| Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttimeacetaminophen, diphenhydramine hcl | Acetaminophen 650 mg/20mL; Diphenhydramine hydrochloride 25 mg/20mL | LiquidOral | Haleon US Holdings LLC | 0031-0101 |
| Throat Comfort Orange Mint Cinnamon Dropsmenthol | Menthol 3.6 mg/1 | LozengeOral | Ricola USA Inc. | 63667-342 |
| Non-Drowsy Sinus Severe, Circle Kacetaminophen, guaifenesin, phenylephrine hcl caplet, film-coated | Guaifenesin 200 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Lil' Drug Store products, Inc. | 66715-5632 |
| COLD, Flu and Sore Throatacetaminophen, guaifenesin, dextromethorphan hydrobromide, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 3 more ingredients | Capsule, Liquid filledOral | Walgreens | 0363-9016 |
| Mucus Relief All in One Maximum Strengthacetaminophen, diphenhydramine hcl phenylephrine hcl | Acetaminophen 650 mg/20mL + 2 more ingredients | LiquidOral | Walgreens | 0363-9130 |
| Pyrilamine Maleate and Dextromethorphan Hydrobromide | Dextromethorphan hydrobromide 7.5 mg/5mL; Pyrilamine maleate 7.5 mg/5mL | LiquidOral | Westminster Pharmaceuticals, LLC | 69367-398 |
| Daytime Cold and Flu Relief Liquid Filled Softgelsacetaminophen, dextromethorphan hbr, phenylephrine hcl | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | AptaPharma Inc. | 76281-604 |
| Cough Dropsmenthol | Menthol 5.8 mg/1 | PastilleOral | Topco Associates LLC | 76162-016 |
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