severe cold and cough
- Product NDC
- 68163-540
- 11-digit product format
- 681630540
- Labeler code
- 68163
- Product ID
- 68163-540_c92ce24f-da56-4e02-81fa-3e34cfb6ba4b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- RARITAN PHARMACEUTICALS INC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-03-14
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 650; 20; 10 mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- severe cold and cough
- Brand name suffix
- daytime
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 650 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1659967 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3ce8508e-7d9d-4413-858a-8f952e760c01 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68163-540-06 | severe cold and coughdaytime | 6 in 1 CARTON | POWDER, FOR SOLUTION | 6 | 7 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68163-540 | SEVERE COLD AND COUGH DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RARITAN PHARMACEUTICALS INC] | 6 | Current NDC, Legacy NDC, 1 package rows | 20241124_3ce8508e-7d9d-4413-858a-8f952e760c01.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Alka-Seltzer Plus Maximum Strength Night Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 51dca689-e4a0-5526-e054-00144ff88e88 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Day Cold and Flu PowerMax Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 6f2d18f6-935f-9215-e053-2a91aa0aedd3 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax Gels | ACETAMINOPHEN, DEXTRMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 6fb28fa1-ebbb-64bf-e053-2991aa0a1de4 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Severe Sinus, Allergy and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 5213ca7f-5a78-6471-e054-00144ff88e88 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Night Cold and Flu PowerMax Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 6f7ba256-ed14-5fe0-e053-2a91aa0aacc1 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | 6f7bf92d-4aaf-86e0-e053-2991aa0a2d91 | 2025-12-04 | Warnings | M012 |
| Afrin NoDrip Allergy Sinus Night | OXYMETAZOLINE HYDROCHLORIDE | Bayer HealthCare LLC. | b023a571-7e54-7c63-e053-2a95a90a0f78 | 2025-12-04 | Warnings | M012 |
| Coricidin HBP Cough and Cold | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROCHLORIDE | Bayer HealthCare LLC. | b1cd7d9f-0ab4-21ce-e053-2a95a90a8c3d | 2025-12-04 | Warnings | M012 |
| Children Afrin No Drip Extra Moisturizing Stuffy Nose Pump Mist Stuffy Nose Pump Mist | OXYMETAZOLINE HYDROCHLORIDE | Bayer HealthCare LLC. | e3231869-8ddf-9d17-e053-2995a90ae6d5 | 2025-12-04 | Warnings | M012 |
| Coricidin HBP Maximum Strength Multi Symptom Flu | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Bayer HealthCare LLC. | ae7cf41e-b618-d6bb-e053-2a95a90a6692 | 2025-12-04 | Warnings | M012 |
| Afrin Allergy Sinus Nasal | OXYMETAZOLINE HYDROCHLORIDE | Bayer HealthCare LLC. | c2d903bf-5c51-82d7-e053-2995a90aea49 | 2025-12-04 | Warnings | M012 |
| Coricidin HBP Maximum Strength Cold, Cough and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | 351d3c5c-05c8-921a-e063-6394a90abef9 | 2025-12-04 | Warnings | M012 |
| Children Afrin Extra Moisturizing Stuffy Nose Pump Mist Stuffy Nose Pump Mist | OXYMETAZOLINE HYDROCHLORIDE | Bayer HealthCare LLC. | e3b239bd-ffc7-600c-e053-2a95a90a3b3b | 2025-12-04 | Warnings | M012 |
| Coricidin HBP Maximum Strength Cold Flu And Chest Congestion | ACETAMINOPHEN, GUAIFENESIN | Bayer HealthCare LLC. | de95d2dd-e766-f7ec-e053-2995a90afc5f | 2025-12-04 | Warnings | M012 |
| Coricidin HBP Maximum Strength Cold and Flu Day and Night | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | e4f3f906-2252-21d1-e053-2a95a90a85df | 2025-12-04 | Warnings | M012 |
| Afrin No Drip Pump Mist Bundle Pack | OXYMETAZOLINE HYDROCHLORIDE | Bayer HealthCare LLC. | 16c52c79-baec-87db-e063-6294a90a3b3b | 2025-12-04 | Warnings | M012 |
| Afrin Original Pump Mist | OXYMETAZOLINE HYDROCHLORIDE | Bayer HealthCare LLC. | 0f5ec576-f788-40aa-9088-0dd672e3cc7c | 2025-12-04 | Warnings | M012 |
| Adult Long Lasting Cough Relief | DEXTROMETHORPHAN HBR | Shield Pharmaceuticals Corp | 432a79a9-c69d-4514-894a-7832e1b745ef | 2025-12-04 | Warnings | M012 |
| GENCONTUSS | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | KRAMER NOVIS | 69d16d25-b09b-430e-8e01-0962d840dc21 | 2025-12-04 | Warnings | M012 |
| Nasal Decongestant PE | PHENYLEPHRINE HCL | H E B | 7c04ab14-af28-4598-90ef-56ac11902c7d | 2025-12-04 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1659967 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral Solution | PSN | 3ce8508e-7d9d-4413-858a-8f952e760c01 | 7 |
| 1659967 | acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution | SCD | 3ce8508e-7d9d-4413-858a-8f952e760c01 | 7 |
| 1659967 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Powder for Oral Solution | SY | 3ce8508e-7d9d-4413-858a-8f952e760c01 | 7 |
| 1659967 | APAP 650 MG / Dextromethorphan Hydrobromide 20 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral Solution | SY | 3ce8508e-7d9d-4413-858a-8f952e760c01 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68163-540-06 | 68163054006 | 6 POWDER, FOR SOLUTION in 1 CARTON (68163-540-06) | 2019-03-14 | 0000-00-00 | No | No | Current |