Alka-Seltzer Plus Cold and Flu
- Product NDC
- 85237-2830
- 11-digit product format
- 852372830
- Labeler code
- 85237
- Product ID
- 85237-2830_5e144020-0ff5-d550-e063-6294a90afff7
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- chlorpheniramine maleate, acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide tablet
- Dosage form
- TABLET, EFFERVESCENT
- Route
- ORAL
- Labeler
- Select Consumer Group
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-04-25
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE
- Active strength
- 250; 10; 5; 2 mg/1; mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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
- Alka-Seltzer Plus Cold and Flu
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 250 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
| CHLORPHENIRAMINE MALEATE | 2 mg/1 |
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 |
|---|---|---|---|---|---|---|
| Stona Cough | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Sato Pharmaceutical Co., Ltd. | 0b638db4-5ed3-4665-abcd-f95e677adbd8 | 2023-11-12 | Warnings | M012 |
| Tylenol Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Jones Healthcare Group - Packaging Services, Inc | 6c90b415-4c5f-49e5-beb6-4cf225797b21 | 2023-11-06 | Warnings | M012 |
| Tylenol Cold Plus Flu Severe Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Jones Healthcare Group - Packaging Services, Inc | 8b8582c0-8aef-482f-9738-2f1d4e325d64 | 2023-11-06 | Warnings | M012 |
| Cold and Flu Severe Daytime/Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | Topco Associates LLC | 27ade5f8-2003-4dc6-9244-42676791e1f8 | 2023-11-06 | Warnings | M012 |
| Benadryl Allergy Ultratab | DIPHENHYDRAMINE HYDROCHLORIDE | Jones Healthcare Group - Packaging Services, Inc | ec2070df-8a8a-4cd1-8830-62655433fb3b | 2023-11-05 | Warnings | M012 |
| Daytime Nighttime Ultra Concentrated Cold and Flu | DAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE | TARGET CORPORATION | 093eed84-79b1-7914-e063-6394a90a37af | 2023-11-03 | Warnings | M012 |
| Cough Drops | MENTHOL | Topco Associates LLC | eff68377-2273-6c6c-e053-2995a90a36b2 | 2023-11-03 | Warnings | M012 |
| Sugar Free Cough Drops | MENTHOL | Topco Associates LLC | 096bbcaa-fce1-0fc2-e063-6294a90ad597 | 2023-11-03 | Warnings | M012 |
| TopCare Nite Time SEVERE Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | adc8edf5-ebbe-4d94-9018-aa0dbe118112 | 2023-11-03 | Warnings | M012 |
| MUCOSA | GUAIFENESIN | TIME CAP LABORATORIES,INC | d34ef2e8-adc2-48e5-a572-e354937daec6 | 2023-11-02 | Warnings | M012 |
| Daytime Severe and Nighttime Severe cold and flu | DAYTIME SEVERE - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN AND NIGHTTIME SEVERE-ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | TARGET CORPORATION | 09286d15-b63f-a9de-e063-6294a90ab948 | 2023-11-02 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | AMERIFOODS TRADING COMPANY | f6cece6c-23e4-7811-e053-6394a90a106a | 2023-11-02 | Warnings | M012 |
| Sinus Pressure plus Pain PE | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | RETAIL BUSINESS SERVICES , LLC. | eb64750f-19ac-655f-e053-2995a90a33b5 | 2023-11-02 | Warnings | M012 |
| Multi-Symptom Mapap Cold Formula | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Proficient Rx LP | 9bf81b26-38b4-486c-ae89-222119ce1a4f | 2023-11-01 | Warnings | M012 |
| Guaifenesin Syrup and Dextromethorphan | GUAIFENESIN SYRUP AND DEXTROMETHORPHAN | Natco Pharma USA LLC | ad9026f4-f0b6-4d02-aa44-f0460eeefc0e | 2023-11-01 | Warnings | M012 |
| Diphenhydramine HCl Oral Solution | DIPHENHYDRAMINE HYDROCHLORIDE | Natco Pharma USA LLC | 54b64354-ac10-42ff-a53d-96cef933a91a | 2023-11-01 | Warnings | M012 |
| children allergy relief dye free cherry | DIPHENHYDRAMINE HCL | A-S Medication Solutions | 5c6c1809-4c6f-4e8f-a5ae-9796e821d400 | 2023-11-01 | Warnings | M012 |
| Daytime and Nighttime Cherry Cold and Flu | DAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE | TARGET CORPORATION | 0903b222-1a44-64aa-e063-6294a90abba0 | 2023-10-31 | Warnings | M012 |
| Ephrine Nose Drops | PHENYLEPHRINE HYDROCHLORIDE | Walgreens | b620eb9f-2caf-0942-e053-2a95a90ae48e | 2023-10-31 | Warnings | M012 |
| pseudoephedrine hydrochloride | PSEUDOEPHEDRINE HCL | A-S Medication Solutions | 204849d1-ac4b-4dbe-8769-fcb30291f880 | 2023-10-31 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85237-2830-1 | 85237283001 | 1 POUCH in 1 CARTON (85237-2830-1) / 2 TABLET, EFFERVESCENT in 1 POUCH (85237-2830-0) | 1 pouch | 2026-09-30 | No | No | Current |
| 85237-2830-2 | 85237283002 | 2 POUCH in 1 CARTON (85237-2830-2) / 2 TABLET, EFFERVESCENT in 1 POUCH (85237-2830-0) | 2 pouch | 2026-09-30 | No | No | Current |
| 85237-2830-3 | 85237283003 | 20 POUCH in 1 CARTON (85237-2830-3) / 2 TABLET, EFFERVESCENT in 1 POUCH (85237-2830-0) | 20 pouch | 2026-09-30 | No | No | Current |
| 85237-2830-4 | 85237283004 | 25 POUCH in 1 CARTON (85237-2830-4) / 2 TABLET, EFFERVESCENT in 1 POUCH (85237-2830-0) | 25 pouch | 2026-09-03 | No | No | Current |
| 85237-2830-5 | 85237283005 | 30 POUCH in 1 CARTON (85237-2830-5) / 2 TABLET, EFFERVESCENT in 1 POUCH (85237-2830-0) | 30 pouch | 2026-09-03 | No | No | Current |