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 |
|---|---|---|---|---|---|---|
| foster and thrive daytime cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Strategic Sourcing Services LLC | 067ce5de-dbb4-4b65-8ec0-f4aacbe5e0a6 | 2026-06-16 | Warnings | M012 |
| Equate Severe Cold Cough and Flu | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | WALMART INC. | a35531d7-1a96-45cb-922f-61db085cde1f | 2026-06-16 | Warnings | M012 |
| Cold and Flu Daytime, Nighttime, Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | 5fe9f313-d6e7-41f5-abfc-e4c72b708961 | 2026-06-15 | Warnings | M012 |
| Pain Relief Sinus Congestion | ACETAMINOPHEN, PHENYLEPHRINE HCL | Better Living Brands, LLC | 1d3d6397-0d92-4145-9a70-8bcc45bd0322 | 2026-06-15 | Warnings | M012 |
| Goodmeds Allergy Relief Diphenhydramine HCl | DIPHENHYDRAMINE HYDROCHLORIDE | Cabinet Health P.B.C. | c1cc40f4-9bbb-47f2-ba3b-a5c46ec10f11 | 2026-06-15 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Rite Aid Corporation | d5d9334d-3db6-4f45-ab84-3e1ec5a752c6 | 2026-06-15 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Geiss, Destin & Dunn Inc. | fac64ddc-a89b-4d73-b9e5-edc4e5cc3c4b | 2026-06-15 | Warnings | M012 |
| equate daytime cold and flu nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Wal-Mart Stores Inc | 983a4783-d826-41b6-8087-ca66bcd5b6ca | 2026-06-12 | Warnings | M012 |
| Equate Daytime Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores Inc | 4173ecde-a2d7-4836-a6e9-fef2270d1b4e | 2026-06-12 | Warnings | M012 |
| PAIN RELIEVER PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Best Choice (Valu Merchandisers Company) | cf370a59-42d5-42fe-882f-09885c55f570 | 2026-06-11 | Warnings | M012 |
| Sudafed Sinus Congestion Plus Cold Severe Day | ACETAMINOPHEN, PSEUDOEPHEDRINE | Kenvue Brands LLC | 537e1a0d-820d-c3f7-e063-6294a90a56ea | 2026-06-10 | Warnings | M012 |
| Sudafed Sinus Congestion plus Cold Severe Day and Night | ACETAMINOPHEN, DIPHENHYDRAMINE, PSEUDOEPHEDRINE | Kenvue Brands LLC | 5382dcad-0337-4440-e063-6394a90a706e | 2026-06-10 | Warnings | M012 |
| good neighbor pharmacy nasal | OXYMETAZOLINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 21cfa71c-7a8f-4100-a42e-9190260653d1 | 2026-06-09 | Warnings | M012 |
| Daytime Nighttime | ACETAMINOPHEN DEXTROMETHORPHAN HBR, ACETAMINOPHEN DEXTROMETHORPHAN HBR TRIPROLIDINE HCL | WALGREENS | 47f1d92f-cb4b-1635-e063-6294a90a2c71 | 2026-06-09 | Warnings | M012 |
| HALLS Honey | MENTHOL | Mondelez Global LLC | 837f5ded-8efb-402b-a1bc-b5c142755660 | 2026-06-09 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Meijer Distribution Inc | 932b11b1-f4a0-417a-bfa1-05261a172155 | 2026-06-08 | Warnings | M012 |
| NO DRIP NASAL MIST | OXYMETAZOLINE HYDROCHLORIDE | Kroger Company | 957efbcf-b6d3-4793-bb6e-27e99c9be905 | 2026-06-08 | Warnings | M012 |
| DAYTIME SEVERE COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 493caecb-e687-49ea-b7a1-2a5b9376896d | 2026-06-08 | Warnings | M012 |
| Severe Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS PHARMACY | 4ad10fd7-c088-4356-9d34-a95cfe3a4133 | 2026-06-08 | Warnings | M012 |
| Theraflu Severe Congestion Relief Nasal Mist | OXYMETAZOLINE HCL | Haleon US Holdings LLC | 4ec42064-7390-4137-a93e-57343c3c76a7 | 2026-06-08 | 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 |