NIGHTTIME SEVERE COLD AND FLU
- Product NDC
- 41226-626
- 11-digit product format
- 412260626
- Labeler code
- 41226
- Product ID
- 41226-626_4716c052-0f4a-2d90-e063-6294a90a9a56
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- KROGER
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2020-05-29
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 10; 325; 6.25; 5 mg/1; mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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 | 41226-626-08 | 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 | 41226-626-08 | 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 | 41226-626-08 | 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 | 41226-626-08 | 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 | 41226-626-08 | 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 | 41226-626-08 | 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 | 41226-626-08 | 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 | 41226-626-08 | 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 | 41226-626-08 | 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
- NIGHTTIME SEVERE COLD AND FLU
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/1 |
| ACETAMINOPHEN | 325 mg/1 |
| DOXYLAMINE SUCCINATE | 6.25 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9D2RTI9KYH | Internal UNII lookup |
| 362O9ITL9D | Internal UNII lookup |
| V9BI9B5YI2 | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| a690f5c5-ff41-4072-e053-2995a90a8e55 | 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 |
| 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 |
| 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 |
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 41226-626-08 | 2025-12-29 | C162847 | 48780-1 | 2cef2736-5991-d83d-e063-dadaa90ab31f | KROGER 626T NIGHTTME SEVERE COLD AND FLU |
| 41226-626-08 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-5991-d83d-e063-dadaa90ab31f | KROGER 626T NIGHTTME SEVERE COLD AND FLU |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 41226-626-08 | NIGHTTIME SEVERE COLD AND FLU | 8 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 8 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 41226-626 | NIGHTTIME SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [KROGER] | 3 | Current NDC, Legacy NDC, 1 package rows | 20200529_a690f5c5-ff41-4072-e053-2995a90a8e55.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 |
|---|---|---|---|---|---|---|
| COLTALIN-DM | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | FORTUNE PHARMACAL COMPANY LIMITED | 33e1bec0-323b-40b7-809a-cb65a71ad0ce | 2026-09-17 | Warnings | M012 |
| Cough and Cold HBP | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Geiss, Destin & Dunn Inc. | 1ea07a01-8779-48c2-a287-b7be866cce7b | 2026-09-10 | Warnings | M012 |
| Childrens Cold and Allergy Relief | BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Strategic Sourcing Services LLC | d64fe757-9948-4727-b5dd-1f8e4e4763e2 | 2026-09-10 | Warnings | M012 |
| Cold and Flu HBP | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE | Kroger Company | fd41e4a4-330f-4409-8ba3-0b3bb6f45bca | 2026-09-10 | Warnings | M012 |
| Nighttime Sleep Aid Berry Flavor | DIPHENHYDRAMINE HYDROCHLORIDE | Raritan Pharmaceuticals Inc | 303d7651-9c8f-4a14-9f2c-7181fa0f003e | 2026-09-09 | Warnings | M012 |
| DRx Choice Fruit Punch | GUAIFENESIN | Raritan Pharmaceuticals Inc | a19d7e1c-c04e-41c6-8af6-ecde96299216 | 2026-09-09 | Warnings | M012 |
| Mucus Relief Cold Flu and Sore Throat Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Raritan Pharmaceuticals Inc | 2cb3e17f-3858-4773-a53f-0860ae6ff1b9 | 2026-09-09 | Warnings | M012 |
| MUCINEX FAST-MAX Liquid Gels Day Night Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Reckitt Benckiser LLC | 3856c1e4-814f-85c4-e063-6394a90ab8a8 | 2026-09-09 | Warnings | M012 |
| DRx Choice Long Acting Cough | DEXTROMETHORPHAN HBR | RARITAN PHARMACEUTICALS | 875b40bd-7955-4048-abbf-7f43d9ea3ac5 | 2026-09-09 | Warnings | M012 |
| severe cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Rite Aid Corporation | 4b8ae971-ab57-4937-a878-72d905d7b849 | 2026-09-09 | Warnings | M012 |
| Cold and Flu Relief | ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | CARDINAL HEALTH 110, LLC. DBA LEADER 70000 | 82ba9a73-60ef-49fd-960f-5ca2bb79555e | 2026-09-09 | Warnings | M012 |
| Mucus Relief DM | DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN | The Kroger Co. | 49829083-5c0a-4620-bfb3-7103642368db | 2026-09-09 | Warnings | M012 |
| DRx Choice Childrens Stuffy Nose and Chest Congestion | GUAIFENESIN AND PHENYLEPHRINE HCL | RARITAN PHARMACEUTICALS | 7a3bb739-ff50-4d29-b270-d6b084906493 | 2026-09-09 | Warnings | M012 |
| DRx Choice Children daytime Cough and Chest Congestion | DEXTROMETHORPHAN HBR AND GUAIFENESIN | RARITAN PHARMACEUTICALS | 25fff2a6-ecb1-4117-bd11-e5ec3e3d09a9 | 2026-09-09 | Warnings | M012 |
| Mucus Relief Severe Congestion and Cough Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Raritan Pharmaceuticals Inc | 8a166067-b492-4742-b74c-28fac87c8d70 | 2026-09-09 | Warnings | M012 |
| DRx Choice maximum strength Severe Cough plus sore throat | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | RARITAN PHARMACEUTICALS | a096cb76-0d1c-4ca8-854a-5199da0bc8f7 | 2026-09-09 | Warnings | M012 |
| Vicks DayQuil VapoCOOL SEVERE COLD and FLU plus CONGESTION | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | The Procter & Gamble Manufacturing Company | efb69cc1-a745-6efc-e053-2a95a90abdc9 | 2026-09-08 | Warnings | M012 |
| Vicks NyQuil VapoCOOL Severe COLD and FLU plus CONGESTION | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE | The Procter & Gamble Manufacturing Company | efb5f0b9-9825-ab23-e053-2995a90a26ab | 2026-09-08 | Warnings | M012 |
| Vicks DayQuil and Nyquil VapoCOOL Severe COLD and FLU plus CONGESTION | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE | The Procter & Gamble Manufacturing Company | f4328b44-cdfa-41aa-e053-2995a90a2728 | 2026-09-08 | Warnings | M012 |
| Vicks childrens Cough Congestion | PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESIN | The Procter & Gamble Manufacturing Company | e2356457-9791-3710-e053-2995a90ad140 | 2026-09-08 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1297288 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | a2508699-08c0-4a22-e053-2a95a90a8a6d | 3 |
| 1656815 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | a2508699-08c0-4a22-e053-2a95a90a8a6d | 3 |
| 1297288 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | a2508699-08c0-4a22-e053-2a95a90a8a6d | 3 |
| 1656815 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | a2508699-08c0-4a22-e053-2a95a90a8a6d | 3 |
| 1297288 | APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule | SY | a2508699-08c0-4a22-e053-2a95a90a8a6d | 3 |
| 1656815 | APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule | SY | a2508699-08c0-4a22-e053-2a95a90a8a6d | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 41226-626-08 | 41226062608 | 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (41226-626-08) | 2020-11-16 | 0000-00-00 | No | No | Current |