Cold and Flu
- Product NDC
- 0363-0401
- 11-digit product format
- 003630401
- Labeler code
- 0363
- Product ID
- 0363-0401_2e480401-f038-4cad-805c-3fe4d5463e95
- 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
- 2011-08-08
- 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
- 2027-12-31
- 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 | 0363-0401 | 0363-0401-34 | D | Discontinued by firm | 2026-10-12 |
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 | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0363-0401 | 0363-0401-34 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0363-0401 | 0363-0401-34 | D | Discontinued by firm | excluded / ndc_excluded.zip | f5e01cc5f278… | a2eaf40c39c3… |
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
- Listing expiration
- 2027-12-31
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 |
|---|---|
| e9d0b6f9-e9f3-431c-9f34-4d63108282a1 | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 0363-0401-34 | 2023-08-07 | Walgreen Co. Cold & Flu Drug Facts |
| 0363-0401-34 | 2023-08-07 | Walgreen Co. Cold & Flu Drug Facts |
| 0363-0401-40 | 2023-08-07 | Walgreen Co. Cold & Flu Drug Facts |
| 0363-0401-40 | 2023-08-07 | Walgreen Co. Cold & Flu Drug Facts |
| 0363-0401-34 | 2023-07-28 | Walgreen Co. Cold & Flu Drug Facts |
| 0363-0401-34 | 2023-07-28 | Walgreen Co. Cold & Flu Drug Facts |
| 0363-0401-40 | 2023-07-28 | Walgreen Co. Cold & Flu Drug Facts |
| 0363-0401-40 | 2023-07-28 | Walgreen Co. Cold & Flu Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0363-0401-40 | daytime nighttime cold and flu | 355 mL in 1 BOTTLE | SOLUTION | 355 mL | 650 mg in 30mL | 11 |
| 0363-0401-34 | Cold and Flu | 237 mL in 1 BOTTLE | SOLUTION | 237 | 8 | |
| 0363-0401-40 | Cold and Flu | 355 mL in 1 BOTTLE | SOLUTION | 355 | 8 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| CVS Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN | CVS PHARMACY | 3148f80f-8a0d-4b6c-85be-79085fc04444 | 2026-08-19 | Warnings | M012 |
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | Rite Aid Corporation | aa7164a7-f842-457d-abee-0740bb8c1c90 | 2026-08-19 | Warnings | M012 |
| CVS | CHILDRENS STUFFY NOSE AND COLD | CVS PHARMACY, INC | 6cff265d-94a3-4617-a366-fe970d97f05a | 2026-08-19 | Warnings | M012 |
| CVS Severe Congestion and Pain Relief | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CVS | 5a8e4320-bae1-4831-b66b-9babfe8888d6 | 2026-08-19 | Warnings | M012 |
| CVS Mucus Relief DM Maximum Strength | DEXTROMETHORPHAN HBR AND GUAIFENESIN | CVS PHARMACY | 0ae0c244-e019-4b35-890c-8e15e3d3f7ce | 2026-08-19 | Warnings | M012 |
| CVS Severe Tussin CF Max | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | CVS PHARMACY | e32881f5-2bb5-4756-aa86-a09473ab590b | 2026-08-19 | Warnings | M012 |
| Good Sense Tussin DM Max | DEXTROMETHORPHAN HBR, GUAIFENESIN | L. Perrigo Company | d2541ef0-a73c-43aa-91ff-fdbce2748c4f | 2026-08-18 | Warnings | M012 |
| CVS Severe Nasal Congestion Relief Clear and Cool | OXYMETAZOLINE HYDROCHLORIDE | CVS PHARMACY, INC. | 5a7e42ee-810c-4bc1-9d8d-fac8e849e126 | 2026-08-18 | Warnings | M012 |
| DAYTIME NIGHTTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Amazon.com Services LLC | 8dd039b4-209a-484a-b15e-741d55087a93 | 2026-08-18 | Warnings | M012 |
| CVS Daytime Cold and Flu Relief | ACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCL | CVS PHARMACY | 558b7ed6-a9f6-452c-90cd-df8258663bf1 | 2026-08-18 | Warnings | M012 |
| Extra Strength Nasal | PHENYLEPHRINE HYDROCHLORIDE | CVS PHARMACY | 7acf1a9a-bd97-48bb-8025-ac26070378a2 | 2026-08-18 | Warnings | M012 |
| Polytussin DM | DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, PYRILAMINE MALEATE | Poly Pharmaceuticals, Inc. | fda8f594-82bf-1781-e053-6294a90ad344 | 2026-08-18 | Warnings | M012 |
| Mucinex Fast-Max DM Max Honey and Berry Flavor | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Reckitt Benckiser LLC | da1f1ef9-a974-4998-8e1d-c1d999596943 | 2026-08-18 | Warnings | M012 |
| CVS Health Ultra Fine Mist | OXYMETAZOLINE HYDROCHLORIDE | CVS PHARMACY, INC. | 89168715-71b1-424e-8dae-fcfa90bc85bf | 2026-08-18 | Warnings | M012 |
| CVS Health Sinus | OXYMETAZOLINE HYDROCHLORIDE | CVS PHARMACY, INC. | c7840511-3a4f-4547-ae90-19b085a5874e | 2026-08-17 | Warnings | M012 |
| CVS Health | NASAL OXYMETAZOLINE HCL | CVS Pharmacy,Inc. | 56f08e70-bf16-4933-97bc-177bc190d12a | 2026-08-17 | Warnings | M012 |
| CVS Health No Drip | ALLERGY NASAL | CVS PHARMACY,INC. | 3e76ffac-07a7-4b6a-bc4c-9cabb653e064 | 2026-08-17 | Warnings | M012 |
| CVS dye-free childrens allergy | DIPHENHYDRAMINE HYDROCHLORIDE | CVS PHARMACY | db5a5eff-1bb1-4d00-8c01-caae7a1c7223 | 2026-08-17 | Warnings | M012 |
| CVS Overnight Cold and Flu Clear and Cool | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | CVS PHARMACY, INC | 2497a011-d7a0-4d69-97e2-bbf25a99b1cc | 2026-08-17 | Warnings | M012 |
| Mucus Relief Cough Cold Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | H E B | 3ef949f5-ac8c-44be-b04d-6996fa59a94b | 2026-08-17 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 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 | 12fd5713-0ae4-4d6a-bf33-7e3d76e10c78 | 11 |
| 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 | 12fd5713-0ae4-4d6a-bf33-7e3d76e10c78 | 11 |
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution | PSN | 12fd5713-0ae4-4d6a-bf33-7e3d76e10c78 | 11 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution | PSN | 12fd5713-0ae4-4d6a-bf33-7e3d76e10c78 | 11 |
| 1113705 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | 12fd5713-0ae4-4d6a-bf33-7e3d76e10c78 | 11 |
| 1043400 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | 12fd5713-0ae4-4d6a-bf33-7e3d76e10c78 | 11 |
| 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 | 12fd5713-0ae4-4d6a-bf33-7e3d76e10c78 | 11 |
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | 12fd5713-0ae4-4d6a-bf33-7e3d76e10c78 | 11 |
| 1043400 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | 12fd5713-0ae4-4d6a-bf33-7e3d76e10c78 | 11 |
| 1113705 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | 12fd5713-0ae4-4d6a-bf33-7e3d76e10c78 | 11 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | 12fd5713-0ae4-4d6a-bf33-7e3d76e10c78 | 11 |
| 1113705 | APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SY | 12fd5713-0ae4-4d6a-bf33-7e3d76e10c78 | 11 |
| 1043400 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | 12fd5713-0ae4-4d6a-bf33-7e3d76e10c78 | 11 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution | PSN | e9d0b6f9-e9f3-431c-9f34-4d63108282a1 | 8 |
| 1043400 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | e9d0b6f9-e9f3-431c-9f34-4d63108282a1 | 8 |
| 1043400 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | e9d0b6f9-e9f3-431c-9f34-4d63108282a1 | 8 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | e9d0b6f9-e9f3-431c-9f34-4d63108282a1 | 8 |
| 1043400 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | e9d0b6f9-e9f3-431c-9f34-4d63108282a1 | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0363-0401-34 | 00363040134 | 237 mL in 1 BOTTLE (0363-0401-34) | 237 ml | 2012-08-15 | 0000-00-00 | No | No | Current |
| 0363-0401-40 | 00363040140 | 355 mL in 1 BOTTLE (0363-0401-40) | 355 ml | 2011-08-08 | 0000-00-00 | No | No | Current |