Over-the-counter drug · OTC MONOGRAPH DRUG
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride NDC 35916-0167
Acetaminophen 325 mg/1 + 3 more ingredients · Capsule, Liquid filled · Oral · SOFTGEL HEALTHCARE PRIVATE LIMITED
NDC codes
FDA NDC DirectoryProduct NDC (as listed)35916-0167Labeler and product segments. Claims need a package NDC.
Product NDC at billing width35916-0167Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 35916-0167-1 | 35916016701 | 2 BLISTER PACK in 1 CARTON (35916-0167-1) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Aug 22, 2024 |
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)
- Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride
- Generic name (nonproprietary)
- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate and phenylephrine hydrochloride
- Active ingredients
- Acetaminophen — 325 mg/1Dextromethorphan hydrobromide — 10 mg/1Phenylephrine hydrochloride — 5 mg/1Doxylamine succinate — 6.25 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- SOFTGEL HEALTHCARE PRIVATE LIMITEDNDC labeler code 35916
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 012
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha1-Agonists (Mechanism)Histamine Receptor Antagonists (Mechanism)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 35916-0167_47c7e929-e897-88c0-e063-6394a90a5821SPL ID 47c7e929-e897-88c0-e063-6394a90a5821SPL set ID 1fcbafaa-c871-db6d-e063-6394a90aab5eRxCUI 1297288UNII 362O9ITL9D, 9D2RTI9KYH, 04JA59TNSJ, V9BI9B5YI2UPC 0335916016716
- Pharmacologic class
- Antihistamine; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist; alpha-1 Adrenergic Agonist
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
N435916016701followed by a unit qualifier and the quantityPackage 35916-0167-01. 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 relieves common cold/flu symptoms: nasal congestion sinus congestion & pressure cough due to minor throat & bronchial irritation Cough to help you sleep minor aches & pains headache fever sore throat runny nose & sneezing reduces swelling of nasal passages temporarily restores free breathing through the nose promotes nasal and/or sinus drainage
Excerpt only. Read the full label for complete information.
About NDC 35916-0167
- What is NDC 35916-0167?
- 35916-0167 is the product NDC for Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride, Acetaminophen 325 mg/1 + 3 more ingredients capsule, liquid filled, listed with the FDA by SOFTGEL HEALTHCARE PRIVATE LIMITED. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride.
- What is the active ingredient?
- Acetaminophen, Dextromethorphan hydrobromide, Phenylephrine hydrochloride, Doxylamine succinate.
- Who is the labeler?
- SOFTGEL HEALTHCARE PRIVATE LIMITED, NDC labeler code 35916. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride?
- 1 other product NDC are listed under this name. See all Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride | Acetaminophen 325 mg/1 + 3 more ingredients | Capsule, Liquid filledOral | Softgel Healthcare Pvt Ltd | 35916-0186 | 35916-0186-0135916-0186-0235916-0186-03 |
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 |
|---|---|---|---|---|
| 12 Hour Nasal Decongestant Extra Moisturizingnasal spray | Oxymetazoline hydrochloride 50 mg/100mL | LiquidNasal | WinCo Foods LLC | 67091-377 |
| 12 Hour Original Nasal Decongestantnasal spray | Oxymetazoline hydrochloride 50 mg/100mL | LiquidNasal | Sheffield Pharmaceuticals LLC | 11527-140 |
| 12 Hour Original Nasal Decongestantnasal spray | Oxymetazoline hydrochloride 50 mg/100mL | LiquidNasal | WinCo Foods LLC | 67091-378 |
| 24-7 Life BY 7-ELEVEN Nighttime Cold and Fluacetaminophen, dextromethorphan hbr, doxylamine succinate solution | Dextromethorphan hydrobromide 30 mg/30mL + 2 more ingredients | SolutionOral | Lil' Drug Store products, Inc. | 66715-6416 |
| 24/7 Life Medicated Chest Rubcamphor, eucalyptus oil, menthol ointment | Eucalyptus oil 1.2 g/100g + 2 more ingredients | OintmentTopical | Lil' Drug Store Products, Inc. | 29485-6536 |
| 4 Way Fast Actingphenylephrine hydrochloride | Phenylephrine hydrochloride 10 mg/mL | SprayNasal | Haleon US Holdings LLC | 0067-2086 |
| 7 Select Maximum Strengthdextromethorphan hbr, guaifenesin | Dextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 400 mg/20mL | SolutionOral | 7-ELEVEN | 10202-740 |
| Acetaminophen 325 mg, Dextromethorphan Hydrobromide 10 mg, Phenlyephrine Hydrochloride 5 mg softgel (DAY-TIME)acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Health Pharma USA LLC | 71679-101 |
| Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mgacetaminophen, dextromethorphan hbr and phenylephrine hcl | Phenylephrine hydrochloride 5 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Softgel Healthcare Private Limited | 35916-0188 |
| Acetaminophen and Diphenhydramine citrate | Acetaminophen 500 mg/1; Diphenhydramine citrate 38 mg/1 | TabletOral | InvaTech Pharma Solutions LLC | 57631-010 |
| Acetaminophen PM Extra Strengthacetaminophen, diphenhydramine hcl | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | United Natural Foods, Inc. dba UNFI | 41163-228 |
| Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr | — | KitOral | CVS Pharmacy, Inc | 51316-984 |
| Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl | Acetaminophen 500 mg/1 + 2 more ingredients | TabletOral | OPMX LLC | 69729-122 |
| Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl | Acetaminophen 500 mg/1 + 2 more ingredients | TabletOral | OPMX LLC | 69729-322 |
| Acetaminophen, Dextromethorphan HBr | Acetaminophen 325 mg/1; Dextromethorphan hydrobromide 10 mg/1 | Capsule, Liquid filledOral | NUVICARE LLC | 84324-036 |
| Acetaminophen, Dextromethorphan HBr ,Guaifenesin | Guaifenesin 200 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Softgel Healthcare Pvt Ltd | 35916-0184 |
| Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Softgel Healthcare Private Limited | 35916-0185 |
| Acetaminophen, Dextromethorphan HBr, Chlorpheniramine Maleate | — | KitOral | CVS Pharmacy, Inc | 51316-609 |
| ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAILFENESIN,PHENLYEPHRINE HCL | Phenylephrine hydrochloride 5 mg/1 + 3 more ingredients | Capsule, Liquid filledOral | Kroger Company | 41226-628 |
| Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Softgel Healthcare Private Limited | 35916-0154 |
Showing 20 of 39.