Day Severe Cold and Night Cold and Flu
- Product NDC
- 49035-586
- 11-digit product format
- 490350586
- Labeler code
- 49035
- Product ID
- 49035-586_2778b43d-a097-6f74-e063-6294a90a2cd2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesin, phenylephrine hydrochloride
- Dosage form
- KIT
- Labeler
- Wal-Mart Stores, Inc.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2018-01-31
- 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
- Day Severe Cold and Night Cold and Flu
- Brand name suffix
- Maximum Strength
- Listing expiration
- 2026-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 7492b381-9eca-4b07-b356-63fdaea14f81 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49035-586-04 | Day Severe Cold and Night Cold and FluMaximum Strength | 1 in 1 CARTON | KIT | 1 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49035-586 | DAY SEVERE COLD AND NIGHT COLD AND FLU MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [WAL-MART STORES, INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20241123_7492b381-9eca-4b07-b356-63fdaea14f81.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 |
|---|---|---|---|---|---|---|
| Banophen | DIPHENHYDRAMINE HCL | A-S Medication Solutions | e1b05e0c-3c61-4e2e-8e6c-ca1ed5bb93cd | 2024-01-08 | Warnings | M012 |
| AXIM DM Max | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | VIVUNT PHARMA LLC | 0e7424ea-461f-5ead-e063-6294a90a41b6 | 2024-01-05 | Warnings | M012 |
| AXIM Night Time - Liquid | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | VIVUNT PHARMA LLC | 0e740063-80d5-c48b-e063-6394a90a3b30 | 2024-01-05 | Warnings | M012 |
| AXIM DayTime - Liquid | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | VIVUNT PHARMA LLC | 0e742e10-daea-6443-e063-6294a90ab5af | 2024-01-05 | Warnings | M012 |
| Diphenhydramine HCl | DIPHENHYDRAMINE HYDROCHLORIDE | PAI Holdings, LLC dba PAI Pharma | 3c3e0dc8-cddd-4f46-9b68-19bac00c07cc | 2024-01-05 | Warnings | M012 |
| Diphenhydramine HCl | DIPHENHYDRAMINE HCL | A-S Medication Solutions | fa12a5a8-bf2d-4991-9d54-9c519e8e04cd | 2024-01-04 | Warnings | M012 |
| NASAL DECONGESTANT PE 10mg | PHENYLPHRINE HCL | YYBA CORP | 05824fc4-ef3f-4ebb-b601-252f76ad60ef | 2024-01-03 | Warnings | M012 |
| Diphenhydramine HCL | DIPHENHYDRAMINE HCL | Proficient Rx LP | 5943d975-77e4-4cbd-b2d9-d699052fe82a | 2024-01-01 | Warnings | M012 |
| Coricidin HBP Cold and Flu | ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE | Proficient Rx LP | ac79a7dd-c26e-47d2-8fb9-768d2d09e507 | 2024-01-01 | Warnings | M012 |
| Oxymethazoline HCL | OXYMETHAZOLINE HCL | Proficient Rx LP | 96883e5f-18b5-4c1c-b984-756cb86be6ff | 2024-01-01 | Warnings | M012 |
| Diphenhydramine HCL | DIPHENHYDRAMINE HCL | Proficient Rx LP | 6e91b9c3-57e8-488b-ac70-d863cdf9d6e8 | 2024-01-01 | Warnings | M012 |
| Good Neighbor Pharmacy Childrens Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | Proficient Rx LP | 9e067482-8735-4476-a82e-438dd24d4289 | 2024-01-01 | Warnings | M012 |
| XL-3 Day Time | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | AptaPharma Inc. | 94e02be4-b8a6-422a-8f66-e6a69e924b2c | 2023-12-30 | Warnings | M012 |
| TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM | DEXTROMETHORPHAN HYDROBROMIDE | AptaPharma Inc. | 8a4c55d0-c472-4e89-9fdb-17ecf0af4856 | 2023-12-30 | Warnings | M012 |
| XL-3 Xtreme | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | AptaPharma Inc. | dff79e0b-edf0-4dd3-a722-fd9beecd6293 | 2023-12-30 | Warnings | M012 |
| TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Salado Sales, Inc. | e25727d0-7dd7-4ef5-b064-7938679f075f | 2023-12-29 | Warnings | M012 |
| Maximum Strength DM MAX | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | H E B | bb56d09d-ecb0-469e-a16f-f9f1a48942a8 | 2023-12-29 | Warnings | M012 |
| Childrens Cough Mucus Relief | DEXTROMETHORPHANN HBR, GUAIFENESIN | Discount Drug Mart | 2c27aca4-e1e2-419a-84c4-857718ca49da | 2023-12-29 | Warnings | M012 |
| Night Time Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Walgreen Company | de2b2e34-62a5-451f-ab68-531d1c9d4d82 | 2023-12-29 | Warnings | M012 |
| H E B MAX SEVERE CONGESTION and COUGH Maxium Strength | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | H E B | d2b016ee-5329-45bf-9d71-d626204169cf | 2023-12-29 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2634364 | {1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule) } Pack | GPCK | 7492b381-9eca-4b07-b356-63fdaea14f81 | 3 |
| 2634364 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule) Pack | PSN | 7492b381-9eca-4b07-b356-63fdaea14f81 | 3 |
| 1297288 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | 7492b381-9eca-4b07-b356-63fdaea14f81 | 3 |
| 1656815 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | 7492b381-9eca-4b07-b356-63fdaea14f81 | 3 |
| 1297288 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | 7492b381-9eca-4b07-b356-63fdaea14f81 | 3 |
| 1656815 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | 7492b381-9eca-4b07-b356-63fdaea14f81 | 3 |
| 2634364 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule) Pack | SY | 7492b381-9eca-4b07-b356-63fdaea14f81 | 3 |
| 1297288 | APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule | SY | 7492b381-9eca-4b07-b356-63fdaea14f81 | 3 |
| 1656815 | APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule | SY | 7492b381-9eca-4b07-b356-63fdaea14f81 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 49035-586-04 | 49035058604 | 1 KIT in 1 CARTON (49035-586-04) * 2 BLISTER PACK in 1 CARTON / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 1 kit | 2018-01-31 | 0000-00-00 | No | No | Current |