NIGHTTIME COLD AND FLU RELIEF
- Product NDC
- 58602-769
- 11-digit product format
- 586020769
- Labeler code
- 58602
- Product ID
- 58602-769_ce31ced0-439e-4668-94aa-fd09cc636669
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aurohealth LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-06-29
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
- Active strength
- 325; 15; 6.25 mg/1; mg/1; mg/1
- 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
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 | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 58602-769-15 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 58602-769-15 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 58602-769-15 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 58602-769-15 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 58602-769-15 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 58602-769-15 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 58602-769-15 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 58602-769-15 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 58602-769-15 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 58602-769-15 | 557ba5c1ecfa… | 9c80585c8c6e… |
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 COLD AND FLU RELIEF
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 15 mg/1 |
| DOXYLAMINE SUCCINATE | 6.25 mg/1 |
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 |
|---|---|
| 1094549 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 70e1bd25-c32e-491f-b383-91d6f74957a0 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58602-769-78 | NIGHTTIME COLD AND FLU RELIEF | 8 in 1 BLISTER PACK | CAPSULE | 8 | 4 | |
| 58602-769-78 | NIGHTTIME COLD AND FLU RELIEF | 3 in 1 CARTON | CAPSULE | 3 | 4 | |
| 58602-769-79 | NIGHTTIME COLD AND FLU RELIEF | 1 in 1 CARTON | CAPSULE | 1 | 4 | |
| 58602-769-79 | NIGHTTIME COLD AND FLU RELIEF | 8 in 1 BLISTER PACK | CAPSULE | 8 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58602-769 | NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE) CAPSULE [AUROHEALTH LLC] | 4 | Current NDC, Legacy NDC, 4 package rows | 20250510_70e1bd25-c32e-491f-b383-91d6f74957a0.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 |
|---|---|---|---|---|---|---|
| Giltuss D | GILTUSS D | Dextrum Laboratories Inc. | 3f17eefb-b625-b0f2-e063-6294a90afd4d | 2025-09-18 | Warnings | M012 |
| Cold and Flu Relief Daytime | ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Major Pharmaceuticals | 6c11c8c8-b2e1-4b9e-80cf-23247c03dd9b | 2025-09-17 | Warnings | M012 |
| Childrens Giltuss Honey DM Cough | DEXTROMETHORPHAN HBR | Dextrum Laboratories Inc | 3effaf4b-28c3-6131-e063-6294a90a17ff | 2025-09-17 | Warnings | M012 |
| AXIV DayTime - Liquid | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | VIVUNT PHARMA LLC | 1872e1ff-2e08-c404-e063-6294a90afa14 | 2025-09-17 | Warnings | M012 |
| AXIV Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | VIVUNT PHARMA LLC | 1323a67c-b9c5-038c-e063-6394a90a5e6b | 2025-09-17 | Warnings | M012 |
| Giltuss Childrens Cough and Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Dextrum Laboratories Inc. | 3f025ef6-79e7-e833-e063-6294a90ab501 | 2025-09-17 | Warnings | M012 |
| AXIV Night Time - Liquid | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | VIVUNT PHARMA LLC | 186f8519-655d-bd21-e063-6294a90a16a8 | 2025-09-17 | Warnings | M012 |
| AXIV NightTime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | VIVUNT PHARMA LLC | 131f6314-c9a1-7af3-e063-6294a90abe6f | 2025-09-17 | Warnings | M012 |
| 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 |
| Nasal Decongestant | PSEUDOEPHEDRINE HCL | L.N.K. International, Inc. | f12b7f07-0b81-4cab-ae0f-43a7bf9b4bc5 | 2025-09-15 | 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 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1094549 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule | PSN | 70e1bd25-c32e-491f-b383-91d6f74957a0 | 4 |
| 1094549 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | 70e1bd25-c32e-491f-b383-91d6f74957a0 | 4 |
| 1094549 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SY | 70e1bd25-c32e-491f-b383-91d6f74957a0 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 58602-769-15 | 58602076915 | 16 CAPSULE in 1 BOTTLE (58602-769-15) | 16 capsule | 2019-12-31 | 0000-00-00 | No | No | Current |
| 58602-769-78 | 58602076978 | 3 BLISTER PACK in 1 CARTON (58602-769-78) / 8 CAPSULE in 1 BLISTER PACK | 3 blister pack | 2024-06-29 | No | No | Current | |
| 58602-769-79 | 58602076979 | 1 BLISTER PACK in 1 CARTON (58602-769-79) / 8 CAPSULE in 1 BLISTER PACK | 1 blister pack | 2024-06-29 | No | No | Current |