Maximum strength Day cold and flu and Night severe cold and flu
- Product NDC
- 49483-726
- 11-digit product format
- 494830726
- Labeler code
- 49483
- Product ID
- 49483-726_fff69901-965d-5372-e053-6394a90a29c2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophe, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl, Triprolidine HCl Tablets
- Dosage form
- KIT
- Labeler
- TIME CAP LABORATORIES,INC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-09-21
- 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
- Maximum strength Day cold and flu and Night severe cold and flu
- Listing expiration
- 2026-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| fff69901-965c-5372-e053-6394a90a29c2 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 30c51294-7ae9-8007-7de6-58222684a0be | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49483-726-64 | Maximum strength Day cold and flu and Night severe cold and flu | 4 in 1 CARTON | KIT | 4 | 1 | |
| 49483-726-64 | Maximum strength Day cold and flu and Night severe cold and flu | 1 in 1 BLISTER PACK | KIT | 1 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49483-726 | MAXIMUM STRENGTH DAY COLD AND FLU AND NIGHT SEVERE COLD AND FLU (ACETAMINOPHE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCL TABLETS) KIT [TIME CAP LABORATORIES,INC] | 1 | Current NDC, 2 package rows | 20231021_fff69901-965c-5372-e053-6394a90a29c2.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 |
|---|---|---|---|---|---|---|
| QUALITY CHOICE Cough Drops Creamy Strawberry | COUGH DROPS CREAMY STRAWBERRY | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 23085717-b2ee-175c-e063-6394a90a7f54 | 2025-12-29 | Warnings | M012 |
| QUALITY CHOICE | COUGH DROPS MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 2307bbe9-7c8f-4eff-e063-6394a90af4c3 | 2025-12-29 | Warnings | M012 |
| Premier Value | COUGH DROPS CHERRY | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 2a2de803-900d-02f4-e063-6394a90a84cc | 2025-12-29 | Warnings | M012 |
| QUALITY CHOICE | COUGH DROPS HONEY LEMON SUGAR FREE | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 2307f3a7-f6e7-8a5d-e063-6394a90ab7eb | 2025-12-29 | Warnings | M012 |
| Premier Value | COUGH DROPS MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 2a2e8fbe-c1c3-79b1-e063-6394a90a4d73 | 2025-12-29 | Warnings | M012 |
| Premier Value | COUGH DROPS HONEY LEMON | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 2a2dfcc3-e599-3102-e063-6394a90ad54a | 2025-12-29 | Warnings | M012 |
| Premier Value | COUGH DROPS BLACK CHERRY SUGAR FREE | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 2a2ead3c-b4d5-ee8f-e063-6294a90a3c39 | 2025-12-29 | Warnings | M012 |
| MGC Health | COUGH DROPS CREAMY STRAWBERRY | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 29f42644-045b-c4b3-e063-6294a90a48fd | 2025-12-29 | Warnings | M012 |
| MGC Health | COUGH DROPS VANILLA HONEY | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 29f45499-bf14-03e4-e063-6394a90a535c | 2025-12-29 | Warnings | M012 |
| MGC Health | COUGH DROPS BLACK CHERRY SUGAR FREE | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 29f3ddcc-9d4e-f1b1-e063-6294a90ac86f | 2025-12-29 | Warnings | M012 |
| Menthol Flavor Cough Drop | MENTHOL FLAVOR COUGH DROP | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 274a5551-4989-d8fe-e063-6394a90aeabf | 2025-12-29 | Warnings | M012 |
| MENTHOL COUGH SUPPRESSANT ORAL ANESTHETIC Cough Drops | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 29f2acaa-2cc8-a999-e063-6294a90a15ce | 2025-12-29 | Warnings | M012 |
| Leader Throat Soothing Drops Creamy Strawberry | THROAT SOOTHING CREAMY STRAWBERRY | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 26a92ecc-6a9c-b569-e063-6394a90a8bcb | 2025-12-29 | Warnings | M012 |
| ValuMeds Allergy Relief Antihistamine Diphenhydramine HCl | DIPHENHYDRAMINE HYDROCHLORIDE | Cabinet Health P.B.C. | a5ceab90-6885-4f3a-b001-97679e03c01b | 2025-12-29 | Warnings | M012 |
| Goodmeds Non-Drowsy Cough Relief | DEXTROMETHORPHAN HYDROBROMIDE | Cabinet Health P.B.C. | 32482083-3f51-41f4-8d20-bedf143e066d | 2025-12-29 | Warnings | M012 |
| Tusnel EX | GUAIFENESIN | Llorens Pharmaceutical International Division, Inc. | 77c16288-68c4-476c-995f-86f505663270 | 2025-12-29 | Warnings | M012 |
| Tusnel DM | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Llorens Pharmaceutical International Division, Inc. | fe457e6d-422d-496c-bcb9-33594f3c42ff | 2025-12-29 | Warnings | M012 |
| Tusnel Diabetic | DEXTROMETHORPHAN, GUAIFENESIN | LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION | 66b3c094-809e-4d2c-bc15-46563de685cb | 2025-12-29 | Warnings | M012 |
| Fortify | MENTHOL | Natures Formulae Health Products Ltd. | 781d53cf-b3dc-3e2b-e053-2a91aa0a7dcd | 2025-12-29 | Warnings | M012 |
| Safetussin PM Nighttime Cough relief | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Kramer Laboratories | 33dd2245-9abd-4b32-ac76-0f45a54c0f33 | 2025-12-29 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2560237 | {1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG / triprolidine hydrochloride 1.25 MG Oral Tablet) } Pack | GPCK | fff69901-965c-5372-e053-6394a90a29c2 | 1 |
| 2560237 | 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 / phenylephrine HCl 5 MG / triprolidine HCl 1.25 MG Oral Tablet) Pack | PSN | fff69901-965c-5372-e053-6394a90a29c2 | 1 |
| 1110988 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | fff69901-965c-5372-e053-6394a90a29c2 | 1 |
| 2549037 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG / triprolidine HCl 1.25 MG Oral Tablet | PSN | fff69901-965c-5372-e053-6394a90a29c2 | 1 |
| 1110988 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | fff69901-965c-5372-e053-6394a90a29c2 | 1 |
| 2549037 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG / triprolidine hydrochloride 1.25 MG Oral Tablet | SCD | fff69901-965c-5372-e053-6394a90a29c2 | 1 |
| 2560237 | 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 / phenylephrine HCl 5 MG / triprolidine HCl 1.25 MG Oral Tablet) Pack | SY | fff69901-965c-5372-e053-6394a90a29c2 | 1 |
| 1110988 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | fff69901-965c-5372-e053-6394a90a29c2 | 1 |
| 2549037 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG / triprolidine hydrochloride 1.25 MG Oral Tablet | SY | fff69901-965c-5372-e053-6394a90a29c2 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 49483-726-64 | 49483072664 | 4 BLISTER PACK in 1 CARTON (49483-726-64) / 1 KIT in 1 BLISTER PACK * 6 TABLET in 1 BLISTER PACK * 4 TABLET in 1 BLISTER PACK | 4 blister pack | 2023-09-21 | No | No | Current |