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 |
|---|---|---|---|---|---|---|
| Sugar Free Honey-Lemon Fishermans Friend Menthol Cough Suppressant | MENTHOL | Lofthouse of Fleetwood, Ltd. | 87ebb4d9-78d7-1c87-e053-2a95a90adb7d | 2025-03-27 | Warnings | M012 |
| REVASOL CHILDRENS ALLERGY | DIPHENHYDRAMINE HCL | Rnv LLC | 3143137f-ef42-5358-e063-6394a90a8ed1 | 2025-03-26 | Warnings | M012 |
| Rompe Pecho SF FLU | DEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE | Efficient Laboratories Inc | bc10695a-9664-4ce3-82bb-820da06129fa | 2025-03-26 | Warnings | M012 |
| SUPRESS-PE Pediatric | GUIAFENESIN, PHENYLEPHRINE HCL | Kramer Novis | a474171d-5c29-4a80-9d37-00613796211a | 2025-03-26 | Warnings | M012 |
| Guaifenesin DM | DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN | Innovida Pharmaeutique Corporation | dd3f806b-2470-4055-94e1-18adac811025 | 2025-03-25 | Warnings | M012 |
| Foster and Thrive childrens cold cough relief dm | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Strategic Sourcing Services LLC | 38b710e3-1d01-4ff4-a6b6-44936f277f49 | 2025-03-25 | Warnings | M012 |
| Revasol Tussin DM Max with Honey | DEXTROMETHORPHAN HBR AND GUAIFENESIN | Rnv LLC | 30da9255-c93a-84d6-e063-6394a90a7c2a | 2025-03-21 | Warnings | M012 |
| REVASOL NIGHTTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE | Rnv LLC | 30dfd8f7-4cc6-d4f2-e063-6394a90aa9c9 | 2025-03-21 | Warnings | M012 |
| Chest Congestion Relief | GUAIFENESIN | Meijer, Inc. | 261a79b3-5704-76f2-e063-6394a90a5ac6 | 2025-03-20 | Warnings | M012 |
| Rompe Tos X Children | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | OPMX LLC | 05cc932d-b412-0710-e063-6394a90a87f6 | 2025-03-19 | Warnings | M012 |
| Rompe Tos X Adults | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | OPMX LLC | 05abb2db-d22e-90b5-e063-6294a90ace3f | 2025-03-19 | Warnings | M012 |
| Sinus Head Congestion | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE | VIVUNT PHARMA LLC | 30a07773-bd6f-b9f2-e063-6394a90ab8aa | 2025-03-18 | Warnings | M012 |
| Halls Sugar Free Black Cherry | MENTHOL | Mondelez Global LLC | bd2a311a-bf0c-4365-af9b-76675c243b22 | 2025-03-16 | Warnings | M012 |
| Medicated Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | TARGET CORPORATION | fbca9627-5e12-048a-e053-6294a90a6e0f | 2025-03-15 | Warnings | M012 |
| Medicated Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | DOLGENCORP, INC. | 0655688e-7c42-507f-e063-6294a90ae498 | 2025-03-15 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | CVS PHARMACY, INC | 1b8d5494-1fcf-4cd0-acc0-34f17d577bd7 | 2025-03-14 | Warnings | M012 |
| Ultra Concentrated Daytime COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | PuraCap Pharmaceutical LLC | 300b2357-933b-fe9a-e063-6294a90aa4b9 | 2025-03-11 | Warnings | M012 |
| Ultra Concentrated Nighttime COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | PuraCap Pharmaceutical LLC | 300bf27f-744f-7366-e063-6394a90acbcb | 2025-03-11 | Warnings | M012 |
| Daytime COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | PuraCap Pharmaceutical LLC | 300c7c7b-ea0b-3650-e063-6294a90a65e8 | 2025-03-11 | Warnings | M012 |
| Rompe Pecho Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | EFFICIENT LABORATORIES INC | 2ec319a8-92bf-4552-86dd-37cbce18980f | 2025-03-11 | 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 |