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 |
|---|---|---|---|---|---|---|
| Rompe Pecho DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Efficient Laboratories Inc | d108c712-bc36-41d7-9ccd-720496b5599e | 2025-10-14 | Warnings | M012 |
| Rompe Pechito DM for Kids | DEXTROMETHORPHAN HBR, GUAIFENESIN | Efficient Laboratories Inc | 004d12e1-6e3d-84c8-e063-6394a90aa653 | 2025-10-14 | Warnings | M012 |
| VANACOF CP Allergy / Cough | CHLOPHEDIANOL HCL, PYRILAMINE MALEATE | GM Pharmaceuticals, INC | 0bdea30a-39da-6611-e063-6394a90aa4cf | 2025-10-14 | Warnings | M012 |
| VANACOF | CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE | GM Pharmaceuticals, INC | cf3886ab-62b3-497a-a587-18cbfbaf3634 | 2025-10-14 | Warnings | M012 |
| Sugar Free Cherry Fishermans Friend Menthol Cough Suppressant | MENTHOL | Lofthouse of Fleetwood, Ltd. | 42d4bafb-b630-487e-b63d-13ad37a59454 | 2025-10-14 | Warnings | M012 |
| SUPRESS A | DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Dextrum Laboratories, Inc | 410c19f7-213d-cd99-e063-6294a90af5a3 | 2025-10-13 | Warnings | M012 |
| TexaClear Pain and Chest Congestion Relief | CHOLINE SALICYLATE,GUAIFENESIN | GM Pharmaceuticals, INC | 672bc78a-2c71-4135-b64a-2b8c40ac688c | 2025-10-13 | Warnings | M012 |
| Vapor Stick | CAMPHOR/MENTHOL | Rejoice International Corp. | 33d1fbf3-d33c-58b9-e063-6294a90ae098 | 2025-10-13 | Warnings | M012 |
| Nitetime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Meijer Distribution Inc | 47f03174-6e91-4529-bbfa-ce58aa7b7d79 | 2025-10-13 | Warnings | M012 |
| Nasal Decongestant Maximum Strength | PSEUDOEPHEDRINE HCL | CHAIN DRUG MARKETING ASSOCIATION INC | db81e32b-0cad-400b-8479-a3b51de92b12 | 2025-10-10 | Warnings | M012 |
| Giltuss Childrens Cough and Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Gil Pharmaceutical Corp | 852b77ae-a5ac-3ead-e053-2a91aa0a54bd | 2025-10-09 | Warnings | M012 |
| Giltuss Cough and Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Gil Pharmaceutical Corp | 8503c956-42a5-7684-e053-2991aa0adb27 | 2025-10-09 | Warnings | M012 |
| Giltuss HBP Cough and Chest Congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Gil Pharmaceutical Corp | 852ceea2-d6a1-6de2-e053-2a91aa0ad50d | 2025-10-09 | Warnings | M012 |
| Giltuss Childrens Cough and Chest Congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Gil Pharmaceutical Corp | 852d5f01-9289-5515-e053-2a91aa0acf32 | 2025-10-09 | Warnings | M012 |
| Giltuss Diabetic Cough and Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Gil Pharmaceutical Corp | 85183b38-ce2a-0e0e-e053-2991aa0a336f | 2025-10-09 | Warnings | M012 |
| Giltuss MultiSymptom Cold and Flu | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Giltuss Pharmaceutical Corp | 8518fd91-981e-de78-e053-2a91aa0afcb2 | 2025-10-09 | Warnings | M012 |
| Giltuss Childrens MultiSymptom Cold and Flu | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Giltuss Pharmaceutical Corp | 852c8cd6-271f-0fa8-e053-2991aa0ab179 | 2025-10-09 | Warnings | M012 |
| Giltuss Allergy Plus Cough and Congestion | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Gil Pharmaceutical Corp | 85065cf3-386d-22d5-e053-2a91aa0a72da | 2025-10-09 | Warnings | M012 |
| Giltuss Honey Cough and Chest Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | Gil Pharmaceutical Corp | a8b2c847-25e9-8714-e053-2995a90a73ce | 2025-10-09 | Warnings | M012 |
| Giltuss Childrens Allergy Plus Cough and Congestion | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Gil Pharmaceutical Corp | 852c5a57-7ee4-3c5c-e053-2a91aa0a1433 | 2025-10-09 | 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 |