Cold and Flu
- Product NDC
- 0363-9012
- Requested package NDC
- 0363-9012-48
- 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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 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 |
|---|---|---|---|---|---|---|
| AXIV DayTime - NightTime 48 Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | VIVUNT PHARMA LLC | 1320e243-344f-98ed-e063-6294a90a0092 | 2025-09-17 | Warnings | M012 |
| AXIV Sinus Severe Mucus | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCLORIDE | VIVUNT PHARMA LLC | 13245298-8b78-e177-e063-6294a90a6bec | 2025-09-17 | Warnings | M012 |
| GoodSense Tussin CF Multi-Symptom Cold, Raspberry | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Geiss, Destin & Dunn Inc. | 3f05cf84-d485-7688-e063-6394a90ae740 | 2025-09-17 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Family Dollar (FAMILY WELLNESS) | 5d7466b4-fdb7-432b-880d-e7aa4a4acbda | 2025-09-17 | Warnings | M012 |
| allergy relief Childrens | DIPHENHYDRAMINE HCL | United Natural Foods, Inc. dba UNFI | e34d8bf5-e12e-453c-93ea-9c7988c4f13d | 2025-09-16 | Warnings | M012 |
| DayTime Cold Flu Non Drowsy | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Harris Teeter, LLC | 67beb9f6-4e0a-4f7b-b50a-4bcd3a01354f | 2025-09-16 | Warnings | M012 |
| DOMETUSS | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Domel Laboratories | 3ebfc62f-27f6-48b2-9bae-bdefbd1d05fe | 2025-09-16 | Warnings | M012 |
| CareOne Severe Congestion Nasal | OXYMETAZOLINE HYDROCHLORIDE | American Sales Company | d1dba68b-c4e1-4afc-9aee-6a51341b89f5 | 2025-09-16 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | FSA Store Inc. (Caring Mills) | e69ef8dc-09d2-46de-aebf-ba735f4cc7ea | 2025-09-16 | Warnings | M012 |
| Menthol Cough Drops Honey Lemon Flavor | MENTHOL HONEY LEMON FLAVOR | CVS Pharmacy | 3ea9a1f2-75b3-c67a-e063-6294a90a8caf | 2025-09-13 | Warnings | M012 |
| Menthol Cough Drops Honey Lemon Flavor | MENTHOL HONEY LEMON FLAVOR | CVS Pharmacy | 3eab4cf9-6fdc-a6fb-e063-6394a90a8633 | 2025-09-13 | Warnings | M012 |
| COLD AND FLU DAYTIME-NIGHTTIME | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | TARGET CORP | 9de9fab3-890a-158d-e053-2a95a90af423 | 2025-09-13 | Warnings | M012 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Precision Dose, Inc. | 4d0f4f5b-3135-4457-bb8f-ad9d28ca5ea4 | 2025-09-12 | Warnings | M012 |
| Nasal Spray, Circle K | OXYMETAZOLINE HYDROCHLORIDE 0.05% SOLUTION | Lil' Drug Store Products, Inc. | 3ea06e88-a2c6-621b-e063-6294a90a1075 | 2025-09-12 | Warnings | M012 |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Harris Teeter, LLC | a0090dc6-0fe5-4ab2-a2cf-6ed19892f363 | 2025-09-12 | Warnings | M012 |
| Multi Symptom Cold and Multi Symptom Nighttime Cold Childrens | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI | CVS Pharmacy | ebf2dbb4-96fa-4bf6-9afd-8aa8b5369f2e | 2025-09-12 | Warnings | M012 |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | FSA Store Inc. (Caring Mills) | 8d7bb31b-a47d-4252-a0a7-79d286179fb9 | 2025-09-12 | Warnings | M012 |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Family Dollar (FAMILY WELLNESS) | 150e5c3a-7c86-4b66-af30-a376df697401 | 2025-09-12 | Warnings | M012 |
| SEVERE COUGH COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 67f8d405-a2ad-4ade-93b4-9b09a0d81d8e | 2025-09-11 | Warnings | M012 |
| equate MAXIMUM STRENGTH DAYTIME SEVERE Cold and Flu SOFTGELS | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | WALMART INC. | 3862aaa5-2281-e8f9-e063-6294a90a0f7e | 2025-09-09 | 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 |