Cold and Flu
- Product NDC
- 0363-9012
- 11-digit product format
- 003639012
- Labeler code
- 0363
- Product ID
- 0363-9012_48c126ee-83f4-680a-e063-6394a90ac8bb
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
- Dosage form
- KIT
- Labeler
- Walgreens
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-08-24
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0363-9012-48 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0363-9012-48 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 0363-9012-48 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 0363-9012-48 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 0363-9012-48 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 0363-9012-48 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 0363-9012-48 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 0363-9012-48 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 0363-9012-48 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
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
- Daytime, Nighttime, Multi-Symptom
- Listing expiration
- 2027-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| fc670515-a820-4ea7-8786-8ae710798b31 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2026-01-19 | Walgreens Non-Drowsy Daytime & Nighttime Cold and Flu |
| 2025-01-30 | Walgreens Non-Drowsy Daytime & Nighttime Cold and Flu |
| 2023-12-11 | Walgreens Non-Drowsy Daytime & Nighttime Cold and Flu |
| 2023-01-30 | Walgreens Non-Drowsy Daytime & Nighttime Cold and Flu |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0363-9012-48 | Cold and FluDaytime, Nighttime, Multi-Symptom | 1 in 1 PACKAGE, COMBINATION | KIT | 1 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0363-9012 | COLD AND FLU DAYTIME, NIGHTTIME, MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [WALGREENS] | 4 | Current NDC, Legacy NDC, 1 package rows | 20231212_fc670515-a820-4ea7-8786-8ae710798b31.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 |
|---|---|---|---|---|---|---|
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | dbc71f58-0704-4d2b-aed1-0dc01f980006 | 2024-06-11 | Warnings | M012 |
| Nighttime Sleep Aid | DIPHENHYDRAMINE HYDROCHLORIDE | TARGET CORPORATION | 135d2212-2122-b7a1-e063-6294a90aa5f5 | 2024-06-07 | Warnings | M012 |
| up and up daytime honey cold flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Target Corporation | 29da4b94-8f8e-48e8-909f-8476e3b39d78 | 2024-06-06 | Warnings | M012 |
| Multi Symptom Cold and Multi Symptom Nighttime Cold Childrens | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI | TARGET Corporation | e3da3003-88e3-4431-8b65-e61e17728901 | 2024-06-04 | Warnings | M012 |
| Dimetapp Cold and Allergy | BROMPHENIRAMINE MALEATE | Foundation Consumer Healthcare | 15c3570c-bd00-8e43-e063-6294a90a8683 | 2024-06-01 | Warnings | M012 |
| Dimetapp Cold and Cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Foundation Consumer Healthcare | 176be362-5237-edd8-e063-6294a90a4aef | 2024-06-01 | Warnings | M012 |
| Dimetapp Nighttime Cold and Cough | DIPHENHYDRAMINE HYDROCHLORIDE | Foundation Consumer Healthcare | 179115ad-d610-99b2-e063-6294a90ae711 | 2024-06-01 | Warnings | M012 |
| Dimetapp Cold and Cough and Nighttime Cold and Cough | DIPHENHYDRAMINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE | Foundation Consumer Healthcare | 179259a9-231e-df03-e063-6294a90a145e | 2024-06-01 | Warnings | M012 |
| Dimetapp Cold and Cough and Dimetapp Nighttime Cold and Cough | BROMPHIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND DIPHENHYDRAMINE HYRDOCHLORIDE | Foundation Consumer Healthcare | 1820e7c7-bc11-9061-e063-6394a90ae581 | 2024-06-01 | Warnings | M012 |
| Theraflu Severe Cold Relief Combo Pack | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL | Haleon US Holdings LLC | 682c5a4b-5ded-4276-903f-1ef1141ae518 | 2024-06-01 | Warnings | M012 |
| Maximum Strength Nasal Decongestant | OXYMETAZOLINE SPRAY | CVS Health | df1f8bda-7bf3-4755-9169-f2a81d824cbe | 2024-05-31 | Warnings | M012 |
| No Drip Nasal Mist | OXYMETAZOLINE SPRAY | CVS Health | a78d29ed-019b-4014-ae6f-c60c75d19c89 | 2024-05-31 | Warnings | M012 |
| Leader Nasal Decongestant | OXYMETAZOLINE HYDROCHLORIDE | Cardinal Health 110,Inc | 6594c117-6ffc-4bda-8bbf-e91c810f2c3f | 2024-05-31 | Warnings | M012 |
| Nighttime Cold and Flu Relief Multi Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | United Natural Foods, Inc. dba UNFI | 1aba9b7c-8328-4a9f-8ce2-39648b2d8ae4 | 2024-05-23 | Warnings | M012 |
| Mucus Relief Severe Congestion and Cough Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | fdf63308-fe7b-4613-a012-ed5e4c9f8ffe | 2024-05-23 | Warnings | M012 |
| Mucus Relief Cold Flu and Sore Throat Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | e61ab02d-f932-403f-a4f7-0ca354607223 | 2024-05-23 | Warnings | M012 |
| Daytime Cold and Flu Relief Multi-Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | United Natural Foods, Inc. dba UNFI | e4f9a846-ab72-4508-b0c5-f7911af2f3d7 | 2024-05-23 | Warnings | M012 |
| Adult Cough Relief | DEXTROMETHORPHAN HBR | QUALITY CHOICE (Chain Drug Marketing Association) | 6e35f30d-9b29-4468-9f5e-1ee2e9ac4b8c | 2024-05-20 | Warnings | M012 |
| Chlorpheniramine Maleate 4 mg | CHLORPHENIRAMINE MALEATE | Bryant Ranch Prepack | 54681242-c861-4415-b5c0-d3ab55b62be1 | 2024-05-17 | Warnings | M012 |
| Dibromm Cold and Allergy | BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | QUALITY CHOICE (Chain Drug Marketing Association) | c830b18b-4427-4530-9bc7-85c2735080d2 | 2024-05-17 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2634564 | {1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule) } Pack | GPCK | fc670515-a820-4ea7-8786-8ae710798b31 | 5 |
| 2634564 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) Pack | PSN | fc670515-a820-4ea7-8786-8ae710798b31 | 5 |
| 1086997 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | fc670515-a820-4ea7-8786-8ae710798b31 | 5 |
| 1094549 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule | PSN | fc670515-a820-4ea7-8786-8ae710798b31 | 5 |
| 1086997 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | fc670515-a820-4ea7-8786-8ae710798b31 | 5 |
| 1094549 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | fc670515-a820-4ea7-8786-8ae710798b31 | 5 |
| 2634564 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) Pack | SY | fc670515-a820-4ea7-8786-8ae710798b31 | 5 |
| 1086997 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SY | fc670515-a820-4ea7-8786-8ae710798b31 | 5 |
| 1094549 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SY | fc670515-a820-4ea7-8786-8ae710798b31 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0363-9012-48 | 00363901248 | 1 KIT in 1 PACKAGE, COMBINATION (0363-9012-48) * 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 1 kit | 2021-08-24 | 0000-00-00 | No | No | Current |