Alka-Seltzer Plus Severe Sinus Cold and Cough
- Product NDC
- 0280-0507
- 11-digit product format
- 002800507
- Labeler code
- 0280
- Product ID
- 0280-0507_452662db-192f-a610-e063-6394a90a4a10
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Bayer HealthCare LLC.
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2015-01-28
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 250; 10; 200; 5 mg/1; mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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
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 Severe Sinus Cold and Cough
- Brand name suffix
- Liquid Gels
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 250 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/1 |
| GUAIFENESIN | 200 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| 495W7451VQ | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1432488 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0dba1329-5b0d-5688-e054-00144ff8d46c | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0280-0507-20 | Alka-Seltzer Plus Severe Sinus Cold and CoughLiquid Gels | 2 in 1 CARTON | CAPSULE, LIQUID FILLED | 2 | 8 | |
| 0280-0507-20 | Alka-Seltzer Plus Severe Sinus Cold and CoughLiquid Gels | 20 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 20 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0280-0507-20 | EA - Each | 0280-0507 | 99c5c10e-b66c-485b-a516-479f2e130412 | 1 | 2019-09-05 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0280-0507 | ALKA-SELTZER PLUS SEVERE SINUS COLD AND COUGH LIQUID GELS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC.] | 7 | Current NDC, Legacy NDC, 2 package rows | 20231205_0dba1329-5b0d-5688-e054-00144ff8d46c.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 |
|---|---|---|---|---|---|---|
| topcare infants pain and fever | ACETAMINOPHEN | Topco Associates LLC | a1145ac3-3e55-4bd5-a53e-6cf869add9a1 | 2024-07-02 | Warnings | M013 |
| Drug Mart Effervescent Pain Relief | ASPIRIN | Discount Drug Mart Inc | 1c35f394-a221-6531-e063-6394a90acb8a | 2024-07-01 | Warnings | M013 |
| Aspirin | ASPIRIN | Wildman Business Group | cdbfcf14-8685-40a9-9778-a3b4329dc1ad | 2024-07-01 | Warnings | M013 |
| Back Pain Relief Extra Strength Doans | MAGNESIUM SALICYLATE | Wildman Business Group | 2e17664f-a83f-48d1-8b2b-37f41eea65b6 | 2024-07-01 | Warnings | M013 |
| Meijer Effervescent Pain Relief | ASPIRIN | Meijer Distribution Inc | 17553911-e0fc-e355-e063-6394a90af7b8 | 2024-06-28 | Warnings | M013 |
| leader childrens pain and fever | ACETAMINOPHEN | Cardinal Health 110, LLC. dba Leader | 4fb4f4b2-c238-4933-b874-08def3b34a28 | 2024-06-26 | Warnings | M013 |
| good neighbor pharmacy pain and fever childrens | ACETAMINOPHEN | Amerisource Bergen | ca0833ef-837b-47dc-8676-e016af96622c | 2024-06-26 | Warnings | M013 |
| leader childrens pain and fever | ACETAMINOPHEN | Cardinal Health 110, LLC. dba Leader | 4a030c3e-8104-4a0a-98c5-6ab469451f20 | 2024-06-26 | Warnings | M013 |
| Childrens Acetaminophen | ACETAMINOPHEN | Padagis Israel Pharmaceuticals Ltd | a426dd82-b2d6-405e-b0af-cfb1310a6e19 | 2024-06-26 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | WALMART INC. (see also Equate) | 7d86a03f-74f4-4b24-b6a6-8747acfe905e | 2024-06-26 | Warnings | M013 |
| leader childrens pain and fever | ACETAMINOPHEN | Cardinal Health 110, LLC. dba Leader | 5bcc5da9-7e64-4308-a5be-2f47a8ca774d | 2024-06-25 | Warnings | M013 |
| Codeine-Guaifenesin | CODEINE PHOSPHATE AND GUAIFENESIN | NuCare Pharmaceuticals,Inc. | 9e691264-d48a-6b48-e053-2995a90a9352 | 2024-06-20 | Warnings | M013 |
| Aspirin | REGULAR STRENGTH ENTERIC COATED ASPIRIN | NuCare Pharmceuticals,Inc. | a0705f4f-55cb-214a-e053-2995a90aa680 | 2024-06-20 | Warnings | M013 |
| Extra Strength Pain Reliever | ACETAMINOPHEN 500 MG | Lil' Drug Store Products, Inc. | ee8e0e79-4da4-101f-e053-2a95a90a30a4 | 2024-06-19 | Warnings | M013 |
| Extra Strength Headache Relief | ACETAMINOPHEN, ASPIRIN, AND CAFFEINE | Lil' Drug Store Products, Inc. | b3a06e4b-0b31-4e2a-8dd1-9de85760477b | 2024-06-19 | Warnings | M013 |
| pain relief | ACETAMINOPHEN | Meijer Distribution Inc | 43c3fe72-a4ef-48a6-bc22-a644919c0c5c | 2024-06-17 | Warnings | M013 |
| Aspirin Regular Strength | ASPIRIN | RETAIL BUSINESS SERVICES , LLC. | 093182a6-3ed8-5a3f-e063-6294a90a354a | 2024-06-14 | Warnings | M013 |
| ACETAMINOPHEN PM | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | RETAIL BUSINESS SERVICES , LLC. | 093199be-e92a-6f60-e063-6294a90a8533 | 2024-06-14 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | RETAIL BUSINESS SERVICES , LLC. | 09315a3d-bb2d-4f06-e063-6294a90a3bd3 | 2024-06-14 | Warnings | M013 |
| Pain Relief Regular Strength | ACETAMINOPHEN | CHAIN DRUG MARKETING ASSOCIATION INC | 613bc633-0426-41a7-aea9-9ff56311b607 | 2024-06-13 | Warnings | M013 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1432488 | acetaminophen 250 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | 0dba1329-5b0d-5688-e054-00144ff8d46c | 8 |
| 1432488 | acetaminophen 250 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | 0dba1329-5b0d-5688-e054-00144ff8d46c | 8 |
| 1432488 | APAP 250 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule | SY | 0dba1329-5b0d-5688-e054-00144ff8d46c | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0280-0507-20 | 00280050720 | 2 BLISTER PACK in 1 CARTON (0280-0507-20) / 20 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 2 blister pack | 2015-01-28 | 0000-00-00 | No | No | Current |