basic care daytime severe cold and flu
- Product NDC
- 72288-357
- Requested package NDC
- 72288-357-62
- 11-digit product format
- 722880357
- Labeler code
- 72288
- Product ID
- 72288-357_c3ad134e-8b8f-41e0-87e7-81c1a5bf999b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Amazon.com Services LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2020-12-10
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 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
- 2027-12-31
- 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
- basic care daytime severe cold and flu
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 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 |
|---|---|
| 1110988 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 50528d29-ce8c-4efb-a86c-17246b017db0 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72288-357-00 | basic care daytime severe cold and flu nighttime cold and flu | 2 in 1 BLISTER PACK | TABLET, FILM COATED | 32 | 10 mg | 4 |
| 72288-357-00 | basic care daytime severe cold and flu nighttime severe cold and flu | 2 in 1 BLISTER PACK | TABLET, FILM COATED | 16 | 5 mg | 3 |
| 72288-357-62 | basic care daytime severe cold and flu | 2 in 1 BLISTER PACK | TABLET, FILM COATED | 2 | 3 | |
| 72288-357-62 | basic care daytime severe cold and flu | 12 in 1 CARTON | TABLET, FILM COATED | 12 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 72288-357 | BASIC CARE DAYTIME SEVERE COLD AND FLU NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE) KIT [AMAZON.COM SERVICES LLC] | 4 | Current NDC, Legacy NDC | 20241116_298d2796-5ae5-4346-b6d2-2ced2dd29dc3.zip |
| 72288-357 | BASIC CARE DAYTIME SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [AMAZON.COM SERVICES LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20241109_50528d29-ce8c-4efb-a86c-17246b017db0.zip |
| 72288-357 | BASIC CARE DAYTIME SEVERE COLD AND FLU NIGHTTIME SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE) KIT [AMAZON.COM SERVICES LLC] | 3 | Current NDC, Legacy NDC | 20241116_9f4daadb-fdaf-4ea9-bad9-7ed9f8cee7f2.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 |
|---|---|---|---|---|---|---|
| Signature Care Nasal Decongestant | OXYMETAZOLINE HYDROCHLORIDE | Safeway | 838d2f11-2ee4-4081-98c8-b87e79aa47c4 | 2024-10-11 | Warnings | M012 |
| Menthol | COUGH SUPPRESSANT | McKesson | 9d4def70-480f-f2fa-e053-2995a90a9877 | 2024-10-10 | Warnings | M012 |
| Menthol | COUGH SUPPRESSANT | McKesson | 9d5b4ef6-4eb8-41f6-e053-2a95a90a1350 | 2024-10-10 | Warnings | M012 |
| Tukol Sugar Free Cough and Cold | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Genomma Lab USA | 95e0a3eb-5a58-4c8b-a70b-fb0cca1e0841 | 2024-10-08 | Warnings | M012 |
| Rompe Pecho CF CF | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Efficient Laboratories Inc | 06e96e0c-f21f-e706-e063-6294a90a0780 | 2024-10-08 | Warnings | M012 |
| Cough Drops | MENTHOL | United Natural Foods, Inc. | f9f0d020-e031-245e-e053-6294a90addb5 | 2024-10-08 | Warnings | M012 |
| Cough Drops | MENTHOL | United Natural Foods, Inc. | fb7ee463-8003-a306-e053-6294a90a8259 | 2024-10-08 | Warnings | M012 |
| Cough Drops | MENTHOL | United Natural Foods, Inc. | fb7e4a84-d2c2-65e5-e053-6394a90a0c72 | 2024-10-08 | Warnings | M012 |
| Cough Drops | CHERRY | United Natural Foods, Inc. | f9f0e853-6997-a49b-e053-6294a90aa4b8 | 2024-10-08 | Warnings | M012 |
| Cough Drops | MENTHOL | United Natural Foods, Inc. | fb7fa728-911d-aaf0-e053-6394a90ace31 | 2024-10-08 | Warnings | M012 |
| Cough Drops | MENTHOL | United Natural Foods, Inc. | fb7f3b84-1e61-eadf-e053-6394a90a9e5c | 2024-10-08 | Warnings | M012 |
| Cough Drops | MENTHOL | United Natural Foods, Inc. | fb7f515f-7302-d153-e053-6394a90a0834 | 2024-10-08 | Warnings | M012 |
| Rompe Pecho NT NT | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Efficient Laboratories Inc | 06faafaa-50a6-c16e-e063-6294a90a49cb | 2024-10-08 | Warnings | M012 |
| Mucus Relief Cough and Congestion DM | GUAIFENESIN AND DEXTROMETHORPHAN HBR | Bryant Ranch Prepack | 8c25285e-e2cd-4e10-af63-5dce8098b615 | 2024-10-08 | Warnings | M012 |
| Severe Throat Sore Drops | MENTHOL | Target Corporation Inc. | 949543d5-5043-ac06-e053-2995a90ab398 | 2024-10-07 | Warnings | M012 |
| Natural Herbal Cough Drops | COUGH DROPS | Target Corporation Inc. | a23ddfa9-19e0-99ee-e053-2a95a90a6856 | 2024-10-07 | Warnings | M012 |
| Cough Drops | SIMPLY MENTHOL COUGH DROPS | Perrigo Direct, Inc. | fb809c63-94f1-bb7a-e053-6294a90a0a39 | 2024-10-07 | Warnings | M012 |
| Cough Drops | SIMPLY CHERRY COUGH DROPS | Perrigo Direct, Inc. | fb808dc5-bf63-836c-e053-6294a90a80aa | 2024-10-07 | Warnings | M012 |
| Cough Drops | SIMPLY HONEY LEMON | Perrigo Direct Inc. | fb898616-d604-b4c3-e053-6294a90a23bf | 2024-10-07 | Warnings | M012 |
| Natural Herb Cough Drops | MENTHOL HERB | CVS Pharmacy | fcd16063-abca-49a0-e053-6294a90acb26 | 2024-10-07 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2634817 | {1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 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 | 298d2796-5ae5-4346-b6d2-2ced2dd29dc3 | 4 |
| 2634817 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Tablet) Pack | PSN | 298d2796-5ae5-4346-b6d2-2ced2dd29dc3 | 4 |
| 1546881 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 298d2796-5ae5-4346-b6d2-2ced2dd29dc3 | 4 |
| 1110988 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 298d2796-5ae5-4346-b6d2-2ced2dd29dc3 | 4 |
| 1546881 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 298d2796-5ae5-4346-b6d2-2ced2dd29dc3 | 4 |
| 1110988 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 298d2796-5ae5-4346-b6d2-2ced2dd29dc3 | 4 |
| 2634817 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Tablet) Pack | SY | 298d2796-5ae5-4346-b6d2-2ced2dd29dc3 | 4 |
| 1546881 | APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet | SY | 298d2796-5ae5-4346-b6d2-2ced2dd29dc3 | 4 |
| 1110988 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 298d2796-5ae5-4346-b6d2-2ced2dd29dc3 | 4 |
| 2634817 | {1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 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 | 9f4daadb-fdaf-4ea9-bad9-7ed9f8cee7f2 | 3 |
| 2634817 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Tablet) Pack | PSN | 9f4daadb-fdaf-4ea9-bad9-7ed9f8cee7f2 | 3 |
| 1546881 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 9f4daadb-fdaf-4ea9-bad9-7ed9f8cee7f2 | 3 |
| 1110988 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 50528d29-ce8c-4efb-a86c-17246b017db0 | 3 |
| 1110988 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 9f4daadb-fdaf-4ea9-bad9-7ed9f8cee7f2 | 3 |
| 1546881 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 9f4daadb-fdaf-4ea9-bad9-7ed9f8cee7f2 | 3 |
| 1110988 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 9f4daadb-fdaf-4ea9-bad9-7ed9f8cee7f2 | 3 |
| 1110988 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 50528d29-ce8c-4efb-a86c-17246b017db0 | 3 |
| 2634817 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Tablet) Pack | SY | 9f4daadb-fdaf-4ea9-bad9-7ed9f8cee7f2 | 3 |
| 1546881 | APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet | SY | 9f4daadb-fdaf-4ea9-bad9-7ed9f8cee7f2 | 3 |
| 1110988 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 9f4daadb-fdaf-4ea9-bad9-7ed9f8cee7f2 | 3 |
| 1110988 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 50528d29-ce8c-4efb-a86c-17246b017db0 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 72288-357-62 | 72288035762 | 12 BLISTER PACK in 1 CARTON (72288-357-62) / 2 TABLET, FILM COATED in 1 BLISTER PACK | 12 blister pack | 2020-12-10 | 0000-00-00 | No | No | Current |