Cold and Flu
- Product NDC
- 55910-573
- 11-digit product format
- 559100573
- Labeler code
- 55910
- Product ID
- 55910-573_b27833be-9457-467e-8882-81ab139f7619
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
- Dosage form
- KIT
- Labeler
- DOLGENCORP, LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2005-08-04
- 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
- Cold and Flu
- Brand name suffix
- Severe Day Time / Night Time
- Listing expiration
- 2027-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| acdcc6ce-c190-4de6-b126-62fe9043112e | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55910-573-08 | Cold and FluSevere Day Time / Night Time | 1 in 1 CARTON | KIT | 1 | 13 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55910-573 | COLD AND FLU SEVERE DAY TIME / NIGHT TIME (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [DOLGENCORP, LLC] | 12 | Current NDC, Legacy NDC, 1 package rows | 20240727_acdcc6ce-c190-4de6-b126-62fe9043112e.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 |
|---|---|---|---|---|---|---|
| Allergy Antihistamine | DIPHENHYDRAMINE HYDROCHLORIDE | KROGER COMPANY | af5053d8-ba02-4cdf-877f-8c1e368dafe0 | 2024-01-10 | Warnings | M012 |
| HISTEX | TRIPROLIDINE HYDROCHLORIDE | Allegis Pharmaceuticals, LLC | cc466d33-cf3e-4f1c-a794-6d3d79903adf | 2024-01-08 | Warnings | M012 |
| HISTEX-DM | DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Allegis Pharmaceuticals, LLC | 836d062c-29f0-4fd7-b65c-771a3bbd52c4 | 2024-01-08 | Warnings | M012 |
| 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 |
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 | acdcc6ce-c190-4de6-b126-62fe9043112e | 13 |
| 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 | acdcc6ce-c190-4de6-b126-62fe9043112e | 13 |
| 1086991 | acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | acdcc6ce-c190-4de6-b126-62fe9043112e | 13 |
| 1110988 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | acdcc6ce-c190-4de6-b126-62fe9043112e | 13 |
| 1086991 | acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | acdcc6ce-c190-4de6-b126-62fe9043112e | 13 |
| 1110988 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | acdcc6ce-c190-4de6-b126-62fe9043112e | 13 |
| 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 | acdcc6ce-c190-4de6-b126-62fe9043112e | 13 |
| 1086991 | APAP 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | acdcc6ce-c190-4de6-b126-62fe9043112e | 13 |
| 1110988 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | acdcc6ce-c190-4de6-b126-62fe9043112e | 13 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55910-573-08 | 55910057308 | 1 KIT in 1 CARTON (55910-573-08) * 8 TABLET, FILM COATED in 1 BLISTER PACK * 8 TABLET, FILM COATED in 1 BLISTER PACK | 1 kit | 2005-08-04 | 0000-00-00 | No | No | Current |