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 | 69618007854 | 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 |
|---|---|---|---|---|
| equate allergy reliefdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | TabletOral | WALMART INC. | 79903-297 |
| Nighttime Severe Cold and Fluacetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl | Doxylamine succinate 12.5 mg/30mL + 3 more ingredients | LiquidOral | Grocery Outlet, Inc. | 85828-775 |
| Complete Cold Reliefacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl | Acetaminophen 650 mg/20mL + 3 more ingredients | SolutionOral | Belmora LLC | 27854-299 |
| Allergy Reliefdiphenhydramine hcl 25 mg | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Lil' Drug Store Products, Inc. | 29485-9285 |
| Sinus Relief Daytime Nighttimeacetaminophen, diphenhydramine hcl, guaifenesin, phenylephrine hcl | — | Kit | Kroger Company | 30142-616 |
| nasal decongestantoxymetazoline hcl | Oxymetazoline hydrochloride .05 g/100mL | SprayNasal | A-S Medication Solutions | 50090-5281 |
| Discount drug mart Extra Moisturizingoxymetazoline hydrochloride | Oxymetazoline hydrochloride .05 g/100mL | SprayNasal | DISCOUNT DRUG MART | 53943-720 |
| Throat Comfort Orange Mint Cinnamon Dropsmenthol | Menthol 3.6 mg/1 | LozengeOral | Ricola Ag | 54305-342 |
| Geri-Tussin DMdextromethorphan hbr, guaifenesin | Dextromethorphan hydrobromide 10 mg/5mL; Guaifenesin 100 mg/5mL | LiquidOral | Geri-Care Pharmaceuticals, Corp | 57896-661 |
| Childrens Cough and Coldchlorpheniramine maleate, dextrometrorphan hbr | Chlorpheniramine maleate 2 mg/10mL; Dextromethorphan hydrobromide 15 mg/10mL | LiquidOral | FAMILY DOLLAR SERVICES INC | 55319-754 |
| Sinus Pressure and Pain Maximum Strengthacetaminophen, phenylephrine hcl | Acetaminophen 325 mg/1; Phenylephrine hydrochloride 5 mg/1 | TabletOral | DOLGENCORP, LLC | 55910-925 |
| Giltuss Sinus and Chest Congestionguaifenesin, phenylephrine hcl | Guaifenesin 388 mg/1; Phenylephrine hydrochloride 10 mg/1 | TabletOral | Gil Pharmaceutical Corp | 58552-332 |
| Robitussin Day and Night Cough Relief Value Packdextromethorphan hydrobromide, guaifenesin, chlorpheniramine maleate | — | Kit | Haleon US Holdings LLC | 0031-2099 |
| Alka-Seltzer Plus Severe Cough Mucus and Congestion Liquid Gelsalka-seltzer plus severe cough mucus and congestion | Phenylephrine hydrochloride 5 mg/1 + 3 more ingredients | Capsule, Liquid filledOral | Bayer HealthCare LLC. | 0280-0505 |
| Mucinex Childrens FreeFrom Multi-Symptom Cold and Stuffy Nosedextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride | Dextromethorphan hydrobromide 5 mg/5mL + 2 more ingredients | SolutionOral | Reckitt Benckiser LLC | 63824-956 |
| Major Nasal Decongestantoxymetazoline hydrochloride | Oxymetazoline hydrochloride .5 mg/mL | SprayNasal | NuCare Pharmaceuticals, Inc. | 68071-3858 |
| Allergy Reliefdiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/1 | Tablet, Film coatedOral | Walgreen Company | 0363-1799 |
| nighttime severe cold and fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride | Acetaminophen 325 mg/15mL + 3 more ingredients | SolutionOral | Walgreen Company | 0363-2029 |
| Allergy Reliefdiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/1 | TabletOral | BIONPHARMA INC. | 69452-445 |
| Multi Symptom Cold and Multi Symptom Nighttime Cold Childrensdextromethorphan hbr, guaifenesin, phenylephrine hci, acetaminophen, diphenhydramine hci, phenylephrine hci | — | Kit | CVS Pharmacy | 69842-820 |
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