COLD AND FLU SEVERE
- Product NDC
- 79481-5034
- 11-digit product format
- 794815034
- Labeler code
- 79481
- Product ID
- 79481-5034_6a3ee451-8569-46b6-b65b-f5d7b8968e3b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
- Dosage form
- KIT
- Labeler
- Meijer Distribution, Inc.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-11-08
- 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
- COLD AND FLU SEVERE
- Brand name suffix
- Daytime, Nighttime
- Listing expiration
- 2026-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 04715af5-e861-496c-834a-233eb7312556 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 79481-5034-8 | COLD AND FLU SEVEREDaytime, Nighttime | 1 in 1 BLISTER PACK | KIT | 1 | 3 | |
| 79481-5034-8 | COLD AND FLU SEVEREDaytime, Nighttime | 2 in 1 CARTON | KIT | 2 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 79481-5034 | COLD AND FLU SEVERE DAYTIME, NIGHTTIME (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION, INC.] | 2 | Current NDC, 2 package rows | 20241109_04715af5-e861-496c-834a-233eb7312556.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 |
|---|---|---|---|---|---|---|
| Basic Care Honey Lemon Cough Drops | MENTHOL | Amazon.com | c0937b13-f679-a764-e053-2a95a90abf89 | 2025-12-05 | Warnings | M012 |
| Basic Care SF Menthol Cough Drops | MENTHOL | Amazon.com | c0946295-7cf0-1bd8-e053-2a95a90af5af | 2025-12-05 | Warnings | M012 |
| Basic Care SF Honey Lemon Cough Drops | MENTHOL | Amazon.com | cf82fb0b-1b4d-def1-e053-2995a90a6fd9 | 2025-12-05 | Warnings | M012 |
| G-DOLOGEN | ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE | Kramer Novis | 7a4e1d64-2510-405f-a1dc-e02a803b6fbd | 2025-12-05 | Warnings | M012 |
| Quality Choice Severe Cold and Cough Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE | Chain Drug Manufacturing Assn | ce658dd5-b683-436e-b16b-0c06f6f87fd9 | 2025-12-04 | Warnings | M012 |
| Quality Choice Maximum Strength | OXYMETAZOLINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION | a87ba15f-b5a9-4983-a721-ca7f705aea86 | 2025-12-04 | Warnings | M012 |
| Quality Choice | PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION | a12e2e66-d2f3-47a6-a915-a309ae828d27 | 2025-12-04 | Warnings | M012 |
| Childrens Mucus Relief Chest Congestion | GUAIFENESIN | Chain Drug Manufacturing Assn | 034d39c0-9aad-4dff-a158-a041b9f0504f | 2025-12-04 | Warnings | M012 |
| Quality Choice | OXYMETAZOLINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION | d01b8fb6-1ddf-4901-bda6-ae608e94a6a4 | 2025-12-04 | Warnings | M012 |
| Childrens Mucus and Cough Relief | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | Chain Drug Manufacturing Assn | 06822a28-3f82-471d-8db5-c5981b263a03 | 2025-12-04 | Warnings | M012 |
| QUALITY CHOICE | PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION | 14596551-dd82-46b3-8eb8-e69efaea105b | 2025-12-04 | Warnings | M012 |
| Daytime Cold and Flu Lil Drug Store Products | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Lil' Drug Store Products, Inc | fd5c20ed-5520-4db0-bfd4-995f043af2a4 | 2025-12-04 | Warnings | M012 |
| Afrin Original | OXYMETAZOLINE HYDROCHLORIDE | Bayer HealthCare LLC. | 89c165ba-3ad5-49b5-a5bb-423dc8e15bad | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cold Powerfast Fizz Night | ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | a2b30c27-b836-f09f-e053-2995a90ac383 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cold PowerFast Fizz | ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | a37c9d9d-52db-23ff-e053-2995a90a8f76 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cold and Cough PowerFast Fizz | ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Bayer Healthcare LLC. | dd7d8a8c-0f91-5ef1-e053-2a95a90a3c6a | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Cough, Mucus and Congestion Day and Night Powermax | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | a68df74d-dd26-3ae9-e053-2995a90a08d6 | 2025-12-04 | Warnings | M012 |
| Circle K Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Lil' Drug Store Products, Inc. | 55662ada-677e-4048-9529-5bca44076316 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu | DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | b13d5132-cb91-3cf6-e053-2a95a90aa47c | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Sinus Congestion and Pain PowerFast Fizz | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | bd97e91f-1ae1-379c-e053-2995a90acfdd | 2025-12-04 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2634819 | {1 (acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet) } Pack | GPCK | 04715af5-e861-496c-834a-233eb7312556 | 3 |
| 2634819 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 Oral Tablet) Pack | PSN | 04715af5-e861-496c-834a-233eb7312556 | 3 |
| 1086991 | acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 04715af5-e861-496c-834a-233eb7312556 | 3 |
| 1110988 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 04715af5-e861-496c-834a-233eb7312556 | 3 |
| 1086991 | acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 04715af5-e861-496c-834a-233eb7312556 | 3 |
| 1110988 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 04715af5-e861-496c-834a-233eb7312556 | 3 |
| 2634819 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 Oral Tablet) Pack | SY | 04715af5-e861-496c-834a-233eb7312556 | 3 |
| 1086991 | APAP 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 04715af5-e861-496c-834a-233eb7312556 | 3 |
| 1110988 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 04715af5-e861-496c-834a-233eb7312556 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 79481-5034-8 | 79481503408 | 2 BLISTER PACK in 1 CARTON (79481-5034-8) / 1 KIT in 1 BLISTER PACK | 2 blister pack | 2024-11-08 | No | No | Current |