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 |
|---|---|---|---|---|---|---|
| NIGHTTIME CHERRY COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | BETTER LIVING BRANDS LLC. | 36924420-f514-4225-e063-6294a90a330c | 2026-03-03 | Warnings | M012 |
| Daytime Nighttime Ultra Concentrated | DAYTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | CVS HEALTH CORP | 4584d701-5a4e-e54e-e063-6394a90a38d6 | 2026-03-03 | Warnings | M012 |
| foster and thrive nighttime cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Sportpharm LLC | 7bdfd2ef-bb99-41f5-97ae-3a02c994bddd | 2026-03-03 | Warnings | M012 |
| Medique at Home Decorel Forte | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Sportpharm LLC | d27b5976-8cc0-4d99-96f6-9069b786affd | 2026-03-03 | Warnings | M012 |
| Tusnel EX | GUAIFENESIN | A-S Medication Solutions | 7f703c9c-2256-4524-9d31-c51919399d26 | 2026-03-03 | Warnings | M012 |
| Cough Relief | DEXTROMETHORPHAN HBR | Best Choice (Valu Merchandisers Company) | f49f1e9a-07ac-443e-9df8-3281d5f35e78 | 2026-03-03 | Warnings | M012 |
| berkley and jensen nasal | OXYMETAZOLINE HYDROCHLORIDE | BJWC | 77cbe75d-4ed9-4a8b-91dc-1cc28af25508 | 2026-03-02 | Warnings | M012 |
| childrens cold and cough relief dm | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Walgreen Company | 6c7c950d-ed48-4428-9e9e-73684cabc699 | 2026-02-28 | Warnings | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | The Kroger Co. | 116146db-719f-4c48-8a8a-1120ea62b0d5 | 2026-02-27 | Warnings, Adverse reactions | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | BIONPHARMA INC. | 1f737b76-14b5-618a-e063-6294a90a19c2 | 2026-02-27 | Warnings | M012 |
| WALGREENS NIGHTTIME ALLERGY RELIEF | DOXYLAMINE SUCCINATE | WALGREENS CO. | a3c7df98-4611-4b61-9c03-5e687364bf74 | 2026-02-27 | Warnings | M012 |
| MEIJER Childrens Allergy Relief Chews | DIPHENHYDRAMINE HCL | MEIJER DISTRIBUTION INC | 3368e081-a3b2-4c03-8bd1-05cc6af0391d | 2026-02-27 | Warnings | M012 |
| CVS PHARMACY Nighttime MS Flu Relief | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND DEXTROMETHOPHAN HBR | CVS PHARMACY | 23cafaa1-34fe-4cef-960b-5f664ea32cb4 | 2026-02-27 | Warnings | M012 |
| Tussin DM Cough and Chest | DEXTROMETHORPHAN HBR, GUAIFENESIN | WinCo Foods, LLC | 402969c9-945c-44b7-b018-b62f427ce571 | 2026-02-26 | Warnings | M012 |
| nasal original | OXYMETAZOLINE HYDROCHLORIDE | HyVee Inc | d997f264-1b4a-4cca-a282-bd9645d55bfd | 2026-02-26 | Warnings | M012 |
| Multi-Symptom Cold and Fever Childrens | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS PHARMACY | 2a569e47-3f17-4fc7-83d6-a3dddfd4987e | 2026-02-25 | Warnings | M012 |
| Cough and Chest Congestion DN, Cough DM Daytime, Nighttime | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 184059b7-9238-480e-be4a-ed105f13c19d | 2026-02-25 | Warnings | M012 |
| Kids Daytime Cough and Nighttime Cough combo pack | DEXTROMETHORPHAN HBR, GUAIFENESIN, CHLORPHENIRAMINE MALEATE | Genexa Inc. | 4bad39f1-86d4-b8a1-e063-6394a90a7a95 | 2026-02-25 | Warnings | M012 |
| dimaphen dm | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Major Pharmaceuticals | 67072a38-1ae7-4e59-bfed-71db0d93215d | 2026-02-25 | Warnings | M012 |
| leader tussin cf | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Cardinal Health 110, LLC. dba Leader | b3e3699b-b36c-453c-8f3b-0001388c8e82 | 2026-02-25 | 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 |