Cold and Flu
- Product NDC
- 0363-0566
- 11-digit product format
- 003630566
- Labeler code
- 0363
- Product ID
- 0363-0566_d8d36729-c04b-4753-8ec1-a630d6a16113
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Walgreen Company
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2011-08-16
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
- Active strength
- 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL
- Pharmacologic classes
- Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 0363-0566 | 0363-0566-34 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 0363-0566 | 0363-0566-43 | D | Discontinued by firm | 2026-08-03 |
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 | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | 0363-0566-43 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 0363-0566-34 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 0363-0566-43 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 0363-0566-43 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 0363-0566-43 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 0363-0566-43 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 0363-0566-43 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 0363-0566-43 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 0363-0566-43 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0363-0566-43 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 0363-0566-43 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 0363-0566-43 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 0363-0566-43 | 557ba5c1ecfa… | 9c80585c8c6e… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cold and Flu
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 650 mg/30mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 30 mg/30mL |
| DOXYLAMINE SUCCINATE | 12.5 mg/30mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| V9BI9B5YI2 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1043400 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| b6d9f421-b236-4660-be7f-85a878f2fc61 | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 0363-0566-34 | 2023-08-04 | Walgreen Co. Cold & Flu Drug Facts |
| 0363-0566-40 | 2023-08-04 | Walgreen Co. Cold & Flu Drug Facts |
| 0363-0566-43 | 2023-08-04 | Walgreen Co. Cold & Flu Drug Facts |
| 0363-0566-50 | 2023-08-04 | Walgreen Co. Cold & Flu Drug Facts |
| 0363-0566-34 | 2023-07-28 | Walgreen Co. Cold & Flu Drug Facts |
| 0363-0566-40 | 2023-07-28 | Walgreen Co. Cold & Flu Drug Facts |
| 0363-0566-43 | 2023-07-28 | Walgreen Co. Cold & Flu Drug Facts |
| 0363-0566-50 | 2023-07-28 | Walgreen Co. Cold & Flu Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0363-0566-34 | Cold and Flu | 237 mL in 1 BOTTLE | SOLUTION | 237 | 12 | |
| 0363-0566-40 | Cold and Flu | 355 mL in 1 BOTTLE | SOLUTION | 355 | 12 | |
| 0363-0566-43 | Cold and Flu | 473 mL in 1 BOTTLE | SOLUTION | 473 | 12 | |
| 0363-0566-50 | Cold and Flu | 2 in 1 PACKAGE | SOLUTION | 2 | 12 | |
| 0363-0566-50 | Cold and Flu | 355 mL in 1 BOTTLE | SOLUTION | 355 | 12 | |
| 0363-0566-40 | daytime nighttime cold and flu | 355 mL in 1 BOTTLE | SOLUTION | 355 mL | 650 mg in 30mL | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0363-0566-40 | ML - Milliliter | 0363-0566 | 631fe488-166e-4fa0-a338-0ad987abb624 | 1 | 2022-06-06 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0363-0566 | COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [WALGREEN COMPANY] | 12 | Current NDC, Legacy NDC, 5 package rows | 20241027_b6d9f421-b236-4660-be7f-85a878f2fc61.zip |
| 0363-0566 | DAYTIME NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [WALGREEN COMPANY] | 4 | Current NDC, Legacy NDC | 20241114_4b49137c-8fc9-43b7-b1a1-82e318237eb6.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 |
|---|---|---|---|---|---|---|
| Severe Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Family Dollar Services Inc | ce590997-3cae-4f22-ac39-2b14d39494bc | 2026-07-30 | Warnings | M012 |
| Robitussin Direct Cough | DEXTROMETHORPHAN HYDROBROMIDE | Haleon US Holdings LLC | 70c9556b-063a-4fb3-96f6-1d4ffa495ed4 | 2026-07-30 | Warnings | M012 |
| Major Nasal Decongestant | OXYMETAZOLINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | a302e341-1c00-4c3d-b71f-c4c0b307aa67 | 2026-07-29 | Warnings | M012 |
| Pain Reliever PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Walgreens | 4c737cd6-fe56-4cef-887c-cd6cf83b254c | 2026-07-29 | Warnings | M012 |
| ROBITUSSIN LONG-ACTING COUGHGELS | DEXTROMETHORPHAN HYDROBROMIDE | Haleon US Holdings LLC | 472c5c1f-eb5a-444b-a17e-f0d71007fb15 | 2026-07-29 | Warnings | M012 |
| DAYTIME COLD AND FLU NITETIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Meijer Distribution Inc | 3a33c6ce-aada-4099-8c61-49c86c0fc1a8 | 2026-07-29 | Warnings | M012 |
| Tussin DM Max Nighttime | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Wal-Mart Stores Inc | 668c92ce-6c1f-4ab3-b0dd-822b0768cb5e | 2026-07-29 | Warnings | M012 |
| Benadryl | DIPHENHYDRAMINE HYDROCHLORIDE | Kenvue Brands LLC | 702f9786-7ce9-43e4-921d-e1db09612127 | 2026-07-28 | Warnings | M012 |
| LoHist-D | CHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCL | Larken Laboratories, Inc. | efaa354e-c25c-405b-9d30-001c2796978c | 2026-07-28 | Warnings | M012 |
| NIGHTTIME SEVERE COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | d1115a55-35cd-4f20-8872-f42983a5ebcd | 2026-07-28 | Warnings | M012 |
| TUSSIN | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Safeway | a5e2bda4-2da6-4c20-855d-2888dadf0c3a | 2026-07-28 | Warnings | M012 |
| DM Maximum | DEXTROMETHORPHAN HBR, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | f6029b04-e681-40fc-be4f-14091b76dd4e | 2026-07-27 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | CVS PHARMACY | e958eef1-8aae-4365-ac64-95a9e8e7e0f2 | 2026-07-27 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | DOLGENCORP INC | 38400854-27fa-e291-e063-6294a90a5c4e | 2026-07-27 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Better Living Brands, LLC | 65802aa7-64e7-4435-ad6b-65895fba17ce | 2026-07-27 | Warnings | M012 |
| Cold and Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCL | Walgreen Company | 0a48f650-ad2a-4105-9ff4-2bc4d94b46d3 | 2026-07-27 | Warnings | M012 |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | 84202ebe-97b6-4be2-bb09-7f2729303f96 | 2026-07-27 | Warnings | M012 |
| Daytime Severe Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Rite Aid Corporation | 8d41defe-8120-4cbb-b42e-c805cc5a794b | 2026-07-24 | Warnings | M012 |
| Childrens Benadryl ALLERGY | DIPHENHYDRAMINE HYDROCHLORIDE | Kenvue Brands LLC | fc9181b9-c92d-493e-8d7c-4a4239c6c092 | 2026-07-24 | Warnings | M012 |
| Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE | Prodose, Inc. | 3afc88c7-388a-dbd9-e063-6294a90a4faf | 2026-07-24 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution | PSN | b6d9f421-b236-4660-be7f-85a878f2fc61 | 12 |
| 1043400 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | b6d9f421-b236-4660-be7f-85a878f2fc61 | 12 |
| 1043400 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | b6d9f421-b236-4660-be7f-85a878f2fc61 | 12 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | b6d9f421-b236-4660-be7f-85a878f2fc61 | 12 |
| 1043400 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | b6d9f421-b236-4660-be7f-85a878f2fc61 | 12 |
| 2637726 | {1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) / 1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution) } Pack | GPCK | 4b49137c-8fc9-43b7-b1a1-82e318237eb6 | 4 |
| 2637726 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution) Pack | PSN | 4b49137c-8fc9-43b7-b1a1-82e318237eb6 | 4 |
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution | PSN | 4b49137c-8fc9-43b7-b1a1-82e318237eb6 | 4 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution | PSN | 4b49137c-8fc9-43b7-b1a1-82e318237eb6 | 4 |
| 1113705 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | 4b49137c-8fc9-43b7-b1a1-82e318237eb6 | 4 |
| 1043400 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | 4b49137c-8fc9-43b7-b1a1-82e318237eb6 | 4 |
| 2637726 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 mL Oral Solution) Pack | SY | 4b49137c-8fc9-43b7-b1a1-82e318237eb6 | 4 |
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | 4b49137c-8fc9-43b7-b1a1-82e318237eb6 | 4 |
| 1043400 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | 4b49137c-8fc9-43b7-b1a1-82e318237eb6 | 4 |
| 1113705 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | 4b49137c-8fc9-43b7-b1a1-82e318237eb6 | 4 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | 4b49137c-8fc9-43b7-b1a1-82e318237eb6 | 4 |
| 1113705 | APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SY | 4b49137c-8fc9-43b7-b1a1-82e318237eb6 | 4 |
| 1043400 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | 4b49137c-8fc9-43b7-b1a1-82e318237eb6 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0363-0566-34 | 00363056634 | 237 mL in 1 BOTTLE (0363-0566-34) | 237 ml | 2012-08-10 | 0000-00-00 | No | No | Current |
| 0363-0566-40 | 00363056640 | 355 mL in 1 BOTTLE (0363-0566-40) | 355 ml | 2011-08-16 | 0000-00-00 | No | No | Current |
| 0363-0566-43 | 00363056643 | 473 mL in 1 BOTTLE | 473 ml | Historical | ||||
| 0363-0566-50 | 00363056650 | 2 BOTTLE in 1 PACKAGE (0363-0566-50) / 355 mL in 1 BOTTLE | 2 bottle | 2011-08-16 | 0000-00-00 | No | No | Current |