equate nighttime cold and flu
- Product NDC
- 49035-324
- 11-digit product format
- 490350324
- Labeler code
- 49035
- Product ID
- 49035-324_539fdc83-1fce-4dff-bc96-963f069bc93d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Wal-Mart Stores Inc
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2020-01-17
- 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 | 49035-324 | 49035-324-34 | D | Discontinued by firm | 2026-10-23 | |
| excluded package | package | 49035-324 | 49035-324-50 | D | Discontinued by firm | 2026-10-23 |
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 | 49035-324-34 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 49035-324-50 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 49035-324-34 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 49035-324-50 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 49035-324-34 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 49035-324-50 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 49035-324-34 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 49035-324-50 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 49035-324-34 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 49035-324-50 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 49035-324-34 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 49035-324-50 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 49035-324-34 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 49035-324-50 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 49035-324-34 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 49035-324-50 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 49035-324-34 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 49035-324-50 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 49035-324-34 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 49035-324-50 | ad56d346431e… | cc804d4bbf1e… |
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
- equate nighttime 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 |
|---|---|
| 6ccbd537-2264-4b3c-804e-3d3ea5368a5f | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e4e263da-1c53-440f-bb80-b7a575843b5a | Product name | 1 | 20260313 |
| d2168cac-a261-415a-9c78-3522859fa720 | Product name | 3 | 20251124 |
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 05a8cdd1-eeb8-409e-b938-0778225eca7d | Product name | 4 | 20250221 |
| e5b5c132-b15d-435b-9faa-2f74e5cadcf9 | Product name | 8 | 20250220 |
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| f489e8f3-5c9e-4818-b539-a73587edcfc7 | Product name | 2 | 20240229 |
| 0f7ae452-206d-4fc4-868d-56fc47074084 | Product name | 1 | 20231011 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49035-324-34 | equate nighttime cold and flu | 237 mL in 1 BOTTLE | SOLUTION | 237 | 5 | |
| 49035-324-40 | equate nighttime cold and flu | 355 mL in 1 BOTTLE | SOLUTION | 355 | 5 | |
| 49035-324-50 | equate nighttime cold and flu | 355 mL in 1 BOTTLE | SOLUTION | 355 | 5 | |
| 49035-324-50 | equate nighttime cold and flu | 2 in 1 CARTON | SOLUTION | 2 | 5 | |
| 49035-324-40 | equate daytime cold and flu nighttime cold and flu | 355 mL in 1 BOTTLE | SOLUTION | 355 mL | 30 mg in 30mL | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49035-324 | EQUATE NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) SOLUTION [WAL-MART STORES INC] | 4 | Current NDC, Legacy NDC, 4 package rows | 20241027_6ccbd537-2264-4b3c-804e-3d3ea5368a5f.zip |
| 49035-324 | EQUATE DAYTIME COLD AND FLU NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [WAL-MART STORES INC] | 3 | Current NDC, Legacy NDC | 20241114_983a4783-d826-41b6-8087-ca66bcd5b6ca.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 Sinus Relief Mist | OXYMETAZOLINE SPRAY | Walgreens Company | 847f47d9-62b1-49a3-8bb3-9bf275685bd2 | 2024-02-14 | Warnings | M012 |
| Allergy Sinus, Lil Drug Store | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATE | Lil' Drug Store Products, Inc. | 1145440e-b37a-6e5e-e063-6294a90ab4a0 | 2024-02-13 | Warnings | M012 |
| Guaifenesin and Codeine Phosphate | GUAIFENESIN AND CODEINE PHOSPHATE | A-S Medication Solutions | 36140639-e7a8-43bc-83e2-469430af9d1a | 2024-02-13 | Warnings | M012 |
| Theraflu ExpressMax Daytime Severe Cold and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Haleon US Holdings LLC | ff48b55a-0d32-47d6-941d-d99c7cf52f94 | 2024-02-12 | Warnings | M012 |
| Childrens Robitussin Cough and Chest Congestion DM | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Haleon US Holdings LLC | 15950273-14c9-4a0b-bbb4-683048add722 | 2024-02-08 | Warnings | M012 |
| THERAFLU Severe Cold Relief Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 7d902237-a990-4c5e-875b-291e124e143b | 2024-02-03 | Warnings | M012 |
| Tussin Cough and Chest Congestion DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Best Choice (Valu Merchandisers Company) | 0f2d371d-f890-41e5-ac11-db5559d32466 | 2024-02-02 | Warnings | M012 |
| Theraflu Severe Cold Relief Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 4daca846-8511-4303-9e6c-9469f7f260ba | 2024-02-02 | Warnings | M012 |
| CVS Health COUGH SUPPRESSANT SOFTGEL | DEXTROMETHORPHAN HYDROBROMIDE | CVS Pharmacy, Inc. | f676dfeb-fba8-419d-8a47-c3880e4100cc | 2024-02-02 | Warnings | M012 |
| Nighttime Cold and Flu ReadyInCase | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | P & L Development, LLC | 155a7168-b568-41f4-b8a2-214889b4eccf | 2024-02-02 | Warnings | M012 |
| Vaporizing Chest Rub Lavender 4oz | CAMPHOR/MENTHOL | Rejoice International Corp. | 104e1a38-3472-b9e2-e063-6294a90a38cf | 2024-02-01 | Warnings | M012 |
| Vaporizing Chest Rub Lavender 4oz | CAMPHOR/MENTHOL | China Ningbo Shangge Cosmetics Technology Corp. | 104f5b07-eed2-566c-e063-6294a90a6505 | 2024-02-01 | Warnings | M012 |
| CHILDRENS COLD COUGH and SORE THROAT MIXED BERRY | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | AptaPharma Inc. | 5962a73e-72e4-493b-94a7-43bc6cf9c82f | 2024-02-01 | Warnings | M012 |
| good sense allergy relief | DIPHENHYDRAMINE HYDROCHLORIDE | L. Perrigo Company | 2cfa69b4-e33f-442a-a6df-b021b041da14 | 2024-02-01 | Warnings | M012 |
| Theraflu Severe Cold Relief Daytime and Theraflu Severe Cold Relief Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL | Haleon US Holdings LLC | e5ef7b85-feee-44a7-bd0e-ed91352c7434 | 2024-01-31 | Warnings | M012 |
| SEVERE CONGESTION and COUGH MAX | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | AptaPharma Inc. | 17a07d2d-f2da-4e51-9a77-6f0c174987bb | 2024-01-31 | Warnings | M012 |
| Maximum strength Max Cold and Sinus | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | AptaPharma Inc. | 263dae13-5f92-4505-8bcc-e903d05b9a0c | 2024-01-31 | Warnings | M012 |
| THERAFLU POWERPODS NIGHTTIME SEVERE COLD | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 39f9feef-4bf2-4f10-9fff-22bbb1d8a471 | 2024-01-30 | Warnings | M012 |
| Theraflu Daytime Severe Cold and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE | Haleon US Holdings LLC | c0689223-5c90-4dbc-bbfa-f94e267504c3 | 2024-01-28 | Warnings | M012 |
| THERAFLU MULTI-SYMPTOM SEVERE COLD | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Haleon US Holdings LLC | a4c56ca0-7785-404b-996d-137cc135f270 | 2024-01-28 | 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 | 6ccbd537-2264-4b3c-804e-3d3ea5368a5f | 5 |
| 1043400 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | 6ccbd537-2264-4b3c-804e-3d3ea5368a5f | 5 |
| 1043400 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | 6ccbd537-2264-4b3c-804e-3d3ea5368a5f | 5 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | 6ccbd537-2264-4b3c-804e-3d3ea5368a5f | 5 |
| 1043400 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | 6ccbd537-2264-4b3c-804e-3d3ea5368a5f | 5 |
| 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 | 983a4783-d826-41b6-8087-ca66bcd5b6ca | 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 | 983a4783-d826-41b6-8087-ca66bcd5b6ca | 4 |
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution | PSN | 983a4783-d826-41b6-8087-ca66bcd5b6ca | 4 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution | PSN | 983a4783-d826-41b6-8087-ca66bcd5b6ca | 4 |
| 1113705 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | 983a4783-d826-41b6-8087-ca66bcd5b6ca | 4 |
| 1043400 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | 983a4783-d826-41b6-8087-ca66bcd5b6ca | 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 | 983a4783-d826-41b6-8087-ca66bcd5b6ca | 4 |
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | 983a4783-d826-41b6-8087-ca66bcd5b6ca | 4 |
| 1043400 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | 983a4783-d826-41b6-8087-ca66bcd5b6ca | 4 |
| 1113705 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | 983a4783-d826-41b6-8087-ca66bcd5b6ca | 4 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | 983a4783-d826-41b6-8087-ca66bcd5b6ca | 4 |
| 1113705 | APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SY | 983a4783-d826-41b6-8087-ca66bcd5b6ca | 4 |
| 1043400 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | 983a4783-d826-41b6-8087-ca66bcd5b6ca | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 49035-324-34 | 49035032434 | 237 mL in 1 BOTTLE (49035-324-34) | 237 ml | 2020-01-17 | 0000-00-00 | No | No | Current |
| 49035-324-40 | 49035032440 | 355 mL in 1 BOTTLE (49035-324-40) | 355 ml | 2020-01-17 | 0000-00-00 | No | No | Current |
| 49035-324-50 | 49035032450 | 2 BOTTLE in 1 CARTON (49035-324-50) > 355 mL in 1 BOTTLE | 2 bottle | 2020-01-17 | 0000-00-00 | No | No | Current |