Alka-Seltzer Plus Maximum Strength Cold and Cough Liquid Gels
- Product NDC
- 0280-1570
- 11-digit product format
- 002801570
- Labeler code
- 0280
- Product ID
- 0280-1570_45267a4c-d227-b1b5-e063-6394a90a81bf
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Bayer HealthCare LLC.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-07-01
- Substance
- CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN
- Active strength
- 2; 5; 10; 325 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
- 2026-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 0280-1570 | D | Discontinued by firm | 2026-10-21 | ||
| excluded package | package | 0280-1570 | 0280-1570-10 | D | Discontinued by firm | 2026-10-21 | |
| excluded package | package | 0280-1570 | 0280-1570-20 | D | Discontinued by firm | 2026-10-21 | |
| excluded package | package | 0280-1570 | 0280-1570-40 | D | Discontinued by firm | 2026-10-21 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0280-1570-20 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0280-1570-40 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0280-1570-10 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0280-1570-20 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0280-1570-40 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0280-1570-10 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 0280-1570-20 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 0280-1570-40 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 0280-1570-10 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 0280-1570-20 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 0280-1570-40 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 0280-1570-10 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 0280-1570-20 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 0280-1570-40 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 0280-1570-10 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 0280-1570-20 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 0280-1570-40 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 0280-1570-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 0280-1570-20 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 0280-1570-40 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 0280-1570-10 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 0280-1570-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 0280-1570-40 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 0280-1570-10 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 0280-1570-20 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 0280-1570-40 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 0280-1570-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 0280-1570-20 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 0280-1570-40 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 0280-1570-10 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 0280-1570-20 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 0280-1570-40 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 0280-1570-10 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 0280-1570-20 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 0280-1570-40 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 0280-1570-10 | 557ba5c1ecfa… | 9c80585c8c6e… |
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 Maximum Strength Cold and Cough Liquid Gels
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CHLORPHENIRAMINE MALEATE | 2 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/1 |
| ACETAMINOPHEN | 325 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| V1Q0O9OJ9Z | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| 362O9ITL9D | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1042688 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 20ae92d9-fbc6-5b7a-e063-6294a90a15c3 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0280-1570-10 | Alka-Seltzer Plus Maximum Strength Cold and Cough Liquid Gels | 1 in 1 CARTON | CAPSULE, LIQUID FILLED | 1 | 2 | |
| 0280-1570-10 | Alka-Seltzer Plus Maximum Strength Cold and Cough Liquid Gels | 10 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 10 | 2 | |
| 0280-1570-20 | Alka-Seltzer Plus Maximum Strength Cold and Cough Liquid Gels | 2 in 1 CARTON | CAPSULE, LIQUID FILLED | 2 | 2 | |
| 0280-1570-20 | Alka-Seltzer Plus Maximum Strength Cold and Cough Liquid Gels | 10 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 10 | 2 | |
| 0280-1570-40 | Alka-Seltzer Plus Maximum Strength Cold and Cough Liquid Gels | 10 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 10 | 2 | |
| 0280-1570-40 | Alka-Seltzer Plus Maximum Strength Cold and Cough Liquid Gels | 4 in 1 CARTON | CAPSULE, LIQUID FILLED | 4 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0280-1570-20 | EA - Each | 0280-1570 | f968c35e-a547-4e42-886e-6956d7f40926 | 1 | 2022-06-06 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0280-1570 | ALKA-SELTZER PLUS MAXIMUM STRENGTH COLD AND COUGH LIQUID GELS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC.] | 1 | Current NDC, Legacy NDC, 6 package rows | 20241115_20ae92d9-fbc6-5b7a-e063-6294a90a15c3.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 |
|---|---|---|---|---|---|---|
| MUCUS RELIEF | GUAIFENESIN 400 MG | Pioneer Life Sciences, LLC | 8188b66a-5405-4e62-bde6-63ebc1f22b16 | 2025-07-04 | Warnings | M012 |
| nasal | OXYMETAZOLINE HYDROCHLORIDE | Meijer, Inc. | fdeadc2e-43e4-40d5-aebf-0e528f0a8b5a | 2025-07-03 | Warnings | M012 |
| Cabinet Allergy Relief Refill Diphenhydramine HCI | DIPHENHYDRAMINE HYDROCHLORIDE | Cabinet Health P.B.C. | d47553a4-ca15-4f0a-8177-d743a5c39cc5 | 2025-07-03 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Advanced Rx LLC | 20e164b8-4cbc-cf3f-e063-6394a90a9d0c | 2025-07-02 | Warnings | M012 |
| 24/7 Life Medicated Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL OINTMENT | Lil' Drug Store Products, Inc. | f03430d4-8dbb-4fc0-e053-2a95a90a119d | 2025-07-02 | Warnings | M012 |
| DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | KJD Pharma Private Limited | b109249a-a0be-41bd-b6ce-ef621b588ddc | 2025-07-02 | Warnings | M012 |
| Daytime Mucus Relief Severe Congestion and Cough and Nighttime Cold and Flu Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | CVS Pharmacy | 91c803c8-6cf8-4ff6-b376-ea6d65f9f227 | 2025-07-01 | Warnings | M012 |
| WALGREENS Dye Free Chidrens Allergy Chews | DIPHENHYDRAMINE HCL | WALGREENS CO. | cc2fdc6b-8319-47c8-b036-37dbd65d5833 | 2025-06-30 | Warnings | M012 |
| WALGREENS Dye Free Chidrens Allergy Chews | DIPHENHYDRAMINE HCL | WALGREENS CO. | 91c369b0-8620-4764-a85d-a86402d9489c | 2025-06-30 | Warnings | M012 |
| Allergy Relief Diphenhydramine HCl 25mg SoftGel | DIPHENHYDRAMINE HYDROCHLORIDE | Pioneer Life Sciences, LLC | bb9a82b1-ea7a-4d10-bc00-05013e83c4d3 | 2025-06-30 | Warnings | M012 |
| Daytime and Nighttime Cherry Cold and Flu | DAYTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL NIGHTTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | BETTER LIVING BRANDS, LLC | 202f0661-461c-0333-e063-6294a90a96b5 | 2025-06-28 | Warnings | M012 |
| Sugar Free Cough Drops | MENTHOL | CVS Pharmacy | f038b713-0721-2bb5-e053-2a95a90a7842 | 2025-06-26 | Warnings | M012 |
| Allergy Relief Diphenhydramine HCl 25mg SoftGel | DIPHENHYDRAMINE HYDROCHLORIDE | NUVICARE LLC | bb728ceb-8eb0-4192-a8b0-742756819a05 | 2025-06-26 | Warnings | M012 |
| ALLERGY RELIEF | DIPHENHYDRAMINE HYDROCHLORIDE | TIME CAP LABORATORIES, INC | 7aee34b5-1583-4a8a-8ffb-b17ef2722ac1 | 2025-06-25 | Warnings | M012 |
| ALLERGY RELIEF | DIPHENHYDRAMINE HYDROCHLORIDE | WALGREENS | c0270298-e7c5-e500-e053-2995a90aed23 | 2025-06-25 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Walmart Inc. | 24ff91f2-02db-56a2-e063-6394a90a31c9 | 2025-06-25 | Warnings | M012 |
| Cough and Chest Congestion Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN | Genexa Inc. | e920b700-30d3-3266-e053-2a95a90a0639 | 2025-06-24 | Warnings | M012 |
| good sense childrens cold cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | L. Perrigo Company | 2ffe0fbc-236d-417b-bbfd-5b9294f3c90a | 2025-06-23 | Warnings | M012 |
| Exchange Select Cough Drop Black Cherry Sugar Free | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 38034ad2-5eab-9caf-e063-6294a90abb8f | 2025-06-20 | Warnings | M012 |
| Herbal Cough Drops | HERBAL MENTHOL | Meijer, Inc. | 380364be-4e52-fa52-e063-6394a90a713c | 2025-06-20 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1042688 | acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | 20ae92d9-fbc6-5b7a-e063-6294a90a15c3 | 2 |
| 1042688 | acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | 20ae92d9-fbc6-5b7a-e063-6294a90a15c3 | 2 |
| 1042688 | APAP 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SY | 20ae92d9-fbc6-5b7a-e063-6294a90a15c3 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0280-1570-10 | 00280157010 | 1 BLISTER PACK in 1 CARTON (0280-1570-10) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 1 blister pack | 2021-03-23 | 0000-00-00 | No | No | Current |
| 0280-1570-20 | 00280157020 | 2 BLISTER PACK in 1 CARTON (0280-1570-20) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 2 blister pack | 2021-03-23 | 0000-00-00 | No | No | Current |
| 0280-1570-40 | 00280157040 | 4 BLISTER PACK in 1 CARTON (0280-1570-40) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 4 blister pack | 2021-03-23 | 0000-00-00 | No | No | Current |