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 |
|---|---|---|---|---|---|---|
| Maximum Strength Mucus Relief | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Hyvee Inc | 4e578c7a-88d4-e4cd-e063-6394a90aac44 | 2026-08-27 | Warnings | M012 |
| MUCUS RELIEF | GUAIFENESIN | Geri-Care Pharmaceuticals, Corp | 5afb242f-fac9-dc81-e063-6394a90a8448 | 2026-08-27 | Warnings | M012 |
| daytime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Amazon.com Services LLC | 6de619d3-0ab0-43e7-8dac-7bbd5368ac65 | 2026-08-27 | Warnings | M012 |
| Daytime Mucus Relief Severe Congestion and Cough and Nighttime Cold and Flu Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI | Walgreens | 366ddac8-9e8a-41bd-a7f7-48213485a5f8 | 2026-08-27 | Warnings | M012 |
| Nighttime Cold and Flu Maximum Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI | Walgreens | 37896933-3ed3-457f-8a32-ee0d784a19e8 | 2026-08-27 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Amazon.com Services LLC | 298e9164-e378-4b39-a944-bfc8f8baa4de | 2026-08-27 | Warnings | M012 |
| DayTime Mucus Relief Severe Cold and Nighttime Cold and Flu Maximum Strength | DAYTIME ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, NIGHTTIME ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI | Walgreens | 3b4b3b04-eff9-4e06-8b37-f6729671d07f | 2026-08-27 | Warnings | M012 |
| Daytime Cold and Flu mini Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Shield Pharmaceuticals Corp | dfb0fe2e-b0c7-409a-bd1a-fd12485665ba | 2026-08-26 | Warnings | M012 |
| Nighttime Severe Cold and Flu Maximum Strength mini softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Shield Pharmaceuticals Corp | 70c5517d-be4e-4317-b4f4-df660c71c699 | 2026-08-26 | Warnings | M012 |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Meijer Distribution, Inc. | c1f9ec75-7eb2-405c-8cdc-097cbf2cf87d | 2026-08-26 | Warnings | M012 |
| Childrens TYLENOL COLD plus COUGH plus RUNNY NOSE | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE | Kenvue Brands LLC | 5b95905e-b729-4caf-921a-fc4ef815289c | 2026-08-25 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Wal-Mart Stores Inc | c88e93d4-66b6-4327-b9e5-0e0a95a18d66 | 2026-08-25 | Warnings | M012 |
| Sleep Aid NightTime | DIPHENHYDRAMINE HCL | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 4fff664b-4ff0-4007-95ab-cb273807b9b4 | 2026-08-25 | Warnings | M012 |
| Vicks Sinex SEVERE CONGESTION MOISTURIZING ULTRA FINE MIST | OXYMETAZOLINE HYDROCHLORIDE | Procter & Gamble Manufacturing GmbH | 464534ee-15f8-3af8-e063-6394a90a3f18 | 2026-08-24 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Walgreen Company | 7d972559-6184-476b-9cbf-1bc5663ea00d | 2026-08-24 | Warnings | M012 |
| Cold, Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Meijer Distribution, Inc. | 9be8437c-6053-4ed4-bdd2-97f556b5289e | 2026-08-24 | Warnings | M012 |
| Extra Strength Tylenol Cold Plus Flu Multi-Symptom Day Night | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE | Kenvue Brands LLC | 594f515c-b369-816d-e063-6294a90a59a1 | 2026-08-21 | Warnings | M012 |
| DG HEALTH MULTI SYMPTOM SEVERE COLD | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Dolgencorp, LLC | 47ddbb0d-0823-4817-9c56-e7fff77d601c | 2026-08-21 | Warnings | M012 |
| Mucus Relief DM Max | DEXTROMETHORPHAN HBR, GUAIFENESIN | DOLGENCORP, LLC | 5be4e730-3cd6-414e-a23b-f6cad8088750 | 2026-08-21 | Warnings | M012 |
| Mucus Relief DM Cough Maximum Strength | DEXTROMETHORPHAN HBR AND GUAIFENESIN | Cardinal Health 110, LLC. DBA Leader | 6304a581-9238-4539-b157-293fc05c173e | 2026-08-21 | 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 |