Alka-Seltzer Plus Cold Medicine Sparkling Original
- Product NDC
- 0280-1400
- 11-digit product format
- 002801400
- Labeler code
- 0280
- Product ID
- 0280-1400_4526711d-1058-262c-e063-6294a90aef61
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ASPIRIN, CHLORPHENIRAMINE MALEATE, and PHENYLEPHRINE BITARTRATE
- Dosage form
- TABLET, EFFERVESCENT
- Route
- ORAL
- Labeler
- Bayer HealthCare LLC.
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2008-04-10
- Substance
- ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE
- Active strength
- 325; 2; 7.8 mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], 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 package | package | 0280-1400 | 0280-1400-12 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 0280-1400 | 0280-1400-20 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 0280-1400 | 0280-1400-36 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 0280-1400 | 0280-1400-48 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 0280-1400 | 0280-1400-72 | D | Discontinued by firm | 2026-10-15 |
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 | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | 0280-1400-48 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 0280-1400-20 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 0280-1400-36 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 0280-1400-12 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 0280-1400-72 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 0280-1400-72 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 0280-1400-48 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 0280-1400-12 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 0280-1400-20 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 0280-1400-36 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 0280-1400-72 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 0280-1400-48 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 0280-1400-12 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 0280-1400-20 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 0280-1400-36 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 0280-1400-72 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 0280-1400-48 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 0280-1400-12 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 0280-1400-20 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 0280-1400-36 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 0280-1400-72 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 0280-1400-48 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 0280-1400-12 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 0280-1400-20 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 0280-1400-36 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 0280-1400-72 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 0280-1400-48 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 0280-1400-12 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 0280-1400-20 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 0280-1400-36 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 0280-1400-72 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 0280-1400-48 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 0280-1400-12 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 0280-1400-20 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 0280-1400-36 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 0280-1400-72 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 0280-1400-48 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 0280-1400-12 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 0280-1400-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 0280-1400-36 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0280-1400-72 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0280-1400-48 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0280-1400-12 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0280-1400-20 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0280-1400-36 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 0280-1400-72 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 0280-1400-48 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 0280-1400-12 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 0280-1400-20 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 0280-1400-36 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 0280-1400-72 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 0280-1400-48 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 0280-1400-12 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 0280-1400-20 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 0280-1400-36 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 0280-1400-72 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 0280-1400-48 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 0280-1400-12 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 0280-1400-20 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 0280-1400-36 | 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 Cold Medicine Sparkling Original
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ASPIRIN | 325 mg/1 |
| CHLORPHENIRAMINE MALEATE | 2 mg/1 |
| PHENYLEPHRINE BITARTRATE | 7.8 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| R16CO5Y76E | Internal UNII lookup |
| V1Q0O9OJ9Z | Internal UNII lookup |
| 27O3Q5ML57 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1536840 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 78537dcf-b157-4b67-a8b2-5cb144815166 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0280-1400-12 | Alka-Seltzer Plus Cold Medicine Sparkling Original | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 9 | |
| 0280-1400-12 | Alka-Seltzer Plus Cold Medicine Sparkling Original | 6 in 1 CARTON | TABLET, EFFERVESCENT | 6 | 9 | |
| 0280-1400-20 | Alka-Seltzer Plus Cold Medicine Sparkling Original | 10 in 1 CARTON | TABLET, EFFERVESCENT | 10 | 9 | |
| 0280-1400-20 | Alka-Seltzer Plus Cold Medicine Sparkling Original | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 9 | |
| 0280-1400-32 | Alka-Seltzer Plus Cold Medicine Sparkling Original | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 9 | |
| 0280-1400-32 | Alka-Seltzer Plus Cold Medicine Sparkling Original | 16 in 1 CARTON | TABLET, EFFERVESCENT | 16 | 9 | |
| 0280-1400-36 | Alka-Seltzer Plus Cold Medicine Sparkling Original | 18 in 1 CARTON | TABLET, EFFERVESCENT | 18 | 9 | |
| 0280-1400-36 | Alka-Seltzer Plus Cold Medicine Sparkling Original | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 9 | |
| 0280-1400-48 | Alka-Seltzer Plus Cold Medicine Sparkling Original | 24 in 1 CARTON | TABLET, EFFERVESCENT | 24 | 9 | |
| 0280-1400-48 | Alka-Seltzer Plus Cold Medicine Sparkling Original | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 9 | |
| 0280-1400-72 | Alka-Seltzer Plus Cold Medicine Sparkling Original | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 9 | |
| 0280-1400-72 | Alka-Seltzer Plus Cold Medicine Sparkling Original | 36 in 1 CARTON | TABLET, EFFERVESCENT | 36 | 9 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0280-1400-36 | EA - Each | 0280-1400 | d9ce5ae8-6625-47f9-ad92-12f7edef8e05 | 1 | 2018-12-13 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0280-1400 | ALKA-SELTZER PLUS COLD MEDICINE SPARKLING ORIGINAL (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [BAYER HEALTHCARE LLC.] | 8 | Current NDC, Legacy NDC, 12 package rows | 20231205_78537dcf-b157-4b67-a8b2-5cb144815166.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 |
|---|---|---|---|---|---|---|
| Pain Reliever | ACETAMINOPHEN | HHH Pharmaceuticals | 0c66b05d-132d-4c79-abfe-415fd68bbb9c | 2026-05-06 | Warnings | M013 |
| Aspirin | ASPIRIN | Better Living Brands, LLC | 5ebd04d8-52c7-4c72-a4c1-fc7fd488ea24 | 2026-05-06 | Warnings | M013 |
| Back and Body Extra Strength | ASPIRIN, CAFFEINE | Cardinal Health 110, LLC. DBA Leader | 519eb216-9fa6-4d60-a2a4-3310bdb5b4ab | 2026-05-06 | Warnings | M013 |
| Aspirin | ASPIRIN | Geiss, Destin & Dunn Inc. | b8f6e486-5332-4c46-ab6c-7de04c91c60b | 2026-05-06 | Warnings | M013 |
| MAX relief junior Grape | CHILDRENS ACETAMINOPHEN | ATLANTIC BIOLOGICALS CORP. | c60494f0-5a50-41da-bcb4-88178ded54b7 | 2026-05-05 | Warnings | M013 |
| equate pain relief pm | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | WALMART INC. | 85129749-c1a7-4c4a-933f-c3c4768e2cdd | 2026-05-05 | Warnings | M013 |
| Acetaminophen Extra Strength | ACETAMINOPHEN | ARMY AND AIR FORCE EXCHANGE SERVICE | f3feca65-adc1-469f-bef6-12c860599abe | 2026-05-04 | Warnings | M013 |
| Childrens Pain and Fever | ACETAMINOPHEN | Strategic Sourcing Services LLC | 4dda3534-4e83-447b-be75-33dadce06c47 | 2026-05-04 | Warnings | M013 |
| Aspirin Low Dose Chewable Orange | ASPIRIN | Major Pharmaceuticals | 4ba6eed3-004a-4576-b7f7-685fae49cf6a | 2026-05-04 | Warnings | M013 |
| Back and Body | ASPIRIN, CAFFEINE | Kroger Company | 366b58db-1ac3-427b-b42a-5f56a14e298c | 2026-05-01 | Warnings | M013 |
| Tylenol PM | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | Savings Distributors LLC | 8ed9a9f0-d37e-5c10-e053-2a95a90a559f | 2026-05-01 | Warnings | M013 |
| Tylenol Extra Strength | ACETAMINOPHEN | Savings Distributors LLC | 8ed90757-833e-f4d9-e053-2995a90a29db | 2026-05-01 | Warnings | M013 |
| Acetaminophen , Aspirin and Caffeine | ACETAMINOPHEN , ASPIRIN AND CAFFEINE | Softgel Healthcare Pvt Ltd | 4543e156-1deb-666e-e063-6394a90a719c | 2026-04-27 | Warnings | M013 |
| Acetaminophen , Caffeine and pyrilamine maleate | ACETAMINOPHEN , CAFFEINE AND PYRILAMINE MALEATE | Softgel Healthcare Pvt Ltd | 45478958-ad86-4d87-e063-6394a90a3c45 | 2026-04-27 | Warnings | M013 |
| Medique at Home Aspirin | ASPIRIN | Sportpharm LLC | 0f2aa75e-534f-478b-811e-fb492b7af9bb | 2026-04-24 | Warnings | M013 |
| Medique at Home APAP Extra Strength | ACETAMINOPHEN 500 MG | Sportpharm LLC | cc280926-ad94-4017-a04a-b4315807eacb | 2026-04-24 | Warnings | M013 |
| Aspirin | ASPIRIN | Health Pharma USA LLC | 503868bb-48e0-b718-e063-6394a90a9c5b | 2026-04-24 | Warnings | M013 |
| BC CHERRY | ASPIRIN AND CAFFEINE | Medtech Products Inc. | c5fa6660-a549-49ff-ac2b-5799afa22ec5 | 2026-04-24 | Warnings | M013 |
| Doans Maximum Strength | MAGNESIUM SALICYLATE | Dr. Reddy's Laboratories Inc. | c906df41-bb45-03ea-b1a8-2b9816d55c97 | 2026-04-24 | Warnings | M013 |
| Extra Strength Acetaminophen | ACETAMINOPHEN | TIME CAP LABORATORIES, INC. | 48912649-9fa1-a11f-e063-6294a90a8a72 | 2026-04-23 | Warnings | M013 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1536840 | aspirin 325 MG / chlorpheniramine maleate 2 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | PSN | 78537dcf-b157-4b67-a8b2-5cb144815166 | 9 |
| 1536840 | aspirin 325 MG / chlorpheniramine maleate 2 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | SCD | 78537dcf-b157-4b67-a8b2-5cb144815166 | 9 |
| 1536840 | ASA 325 MG / Chlorpheniramine Maleate 2 MG / Phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | SY | 78537dcf-b157-4b67-a8b2-5cb144815166 | 9 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0280-1400-12 | 00280140012 | 2 in 1 POUCH | Historical | |||||
| 0280-1400-20 | 00280140020 | 10 in 1 CARTON | Historical | |||||
| 0280-1400-32 | 00280140032 | 16 POUCH in 1 CARTON (0280-1400-32) / 2 TABLET, EFFERVESCENT in 1 POUCH | 16 pouch | 2008-04-10 | 0000-00-00 | No | No | Current |
| 0280-1400-36 | 00280140036 | 18 in 1 CARTON | Historical | |||||
| 0280-1400-48 | 00280140048 | 24 in 1 CARTON | Historical | |||||
| 0280-1400-72 | 00280140072 | 2 in 1 POUCH | Historical |