all nite
- Product NDC
- 0904-6465
- 11-digit product format
- 009046465
- Labeler code
- 0904
- Product ID
- 0904-6465_9bfd7bea-ca99-41ae-a92f-4c91ac3327f3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2012-11-19
- 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
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
- all nite
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 650 mg/30mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 30 mg/30mL |
| DOXYLAMINE SUCCINATE | 12.5 mg/30mL |
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 |
|---|---|---|---|---|---|---|
| 0904-6465-09 | all nite | 237 mL in 1 BOTTLE | SOLUTION | 237 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-6465-09 | ML - Milliliter | 0904-6465 | 0311bb96-dabb-460d-b725-f5d4a1248301 | 1 | 2016-07-19 |
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 |
|---|---|---|---|---|---|---|
| Giltuss Honey DM Cough | DEXTROMETHORPHAN HBR | Dextrum Laboratories, Inc | 3f79137f-f0b0-d22c-e063-6394a90a7245 | 2025-09-23 | Warnings | M012 |
| GoodSense Medicated Chest Rub | CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL | GOOD SENSE | 240bb6af-9d38-49fe-9011-3016246b0986 | 2025-09-23 | Warnings | M012 |
| Xpect Honey Lemon Cough Drops | HONEY LEMON COUGH DROPS | Cintas Corporation | 79e0b7c1-4acc-41d2-89cd-d075a8bac0c9 | 2025-09-23 | Warnings | M012 |
| Topcare NiteTime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Topco Associates LLC | b2b3c450-e988-41d1-9e53-cc8e30d75cb4 | 2025-09-23 | Warnings | M012 |
| Xpect Cherry Cough Drops | CHERRY COUGH DROPS | Cintas Corporation | d1fd2f23-5435-405d-a7fd-644691f79e80 | 2025-09-23 | Warnings | M012 |
| Topcare DayTime NiteTime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Topco Associates LLC | 560fb22b-391f-4d7b-a6fd-38d577d404b0 | 2025-09-23 | Warnings | M012 |
| Giltuss EX Expectorant | GUAIFENESIN | Dextrum Laboratories Inc. | 3f67ac3d-1503-3418-e063-6394a90a938f | 2025-09-22 | Warnings | M012 |
| Giltuss HBP Cough and Chest Congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Dextrum Laboratories Inc. | 3f68e68a-cf32-9df8-e063-6394a90a3012 | 2025-09-22 | Warnings | M012 |
| SUPRESS A | DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Kramer Novis | f0bec5f5-4d76-471e-9024-557eba848b93 | 2025-09-22 | Warnings | M012 |
| RIGHT REMEDIES NIGHTTIME SEVERE COLD AND FLU softgel | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Strive Pharmaceuticals Inc. | 9f050fb0-6100-4b14-b82f-1d5fcbf16540 | 2025-09-22 | Warnings | M012 |
| RIGHT REMEDIES DAYTIME SEVERE COLD AND FLU softgel | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Strive Pharmaceuticals Inc. | c6392ace-c7d1-4450-8b71-4dccc60b4f02 | 2025-09-22 | Warnings | M012 |
| Giltuss Cough and Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Dextrum Laboratories Inc. | 3f12ee8f-d1c6-d73a-e063-6394a90a9199 | 2025-09-18 | Warnings | M012 |
| CVS Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | CVS Pharmacy | 3d71d306-893a-e73a-e063-6394a90a0a3b | 2025-09-18 | Warnings | M012 |
| 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 |
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 | 945a4068-3630-4f1d-b794-d2f1603af285 | 5 |
| 1043400 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | 945a4068-3630-4f1d-b794-d2f1603af285 | 5 |
| 1043400 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | 945a4068-3630-4f1d-b794-d2f1603af285 | 5 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | 945a4068-3630-4f1d-b794-d2f1603af285 | 5 |
| 1043400 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | 945a4068-3630-4f1d-b794-d2f1603af285 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0904-6465-09 | 00904646509 | 237 mL in 1 BOTTLE (0904-6465-09) | 237 ml | 2012-11-19 | 0000-00-00 | No | No | Current |