Nighttime Cold and Cough
- Product NDC
- 82673-191
- 11-digit product format
- 826730191
- Labeler code
- 82673
- Product ID
- 82673-191_dc74d4ef-7829-48a9-ae25-76fb92f1141c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine HCl
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- KinderFarms, LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-05-30
- Marketing end
- 2027-12-28
- Substance
- DIPHENHYDRAMINE HYDROCHLORIDE
- Active strength
- 12.5 mg/5mL
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- 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
- Nighttime Cold and Cough
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | 12.5 mg/5mL |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 82673-191-04 | Nighttime Cold and Cough | 118 mL in 1 BOTTLE, PLASTIC | LIQUID | 118 | 5 | |
| 82673-191-04 | Nighttime Cold and Cough | 1 in 1 BOX | LIQUID | 1 | 5 | |
| 82673-191-04 | Daytime Cough Congestion Nighttime Cold Cough | 118 mL in 1 BOTTLE, PLASTIC | LIQUID | 118 mL | 12.5 mg in 5mL | 3 |
| 82673-191-04 | Daytime Cough Congestion Nighttime Cold Cough | 1 in 1 BOX | LIQUID | 12.5 mg in 5mL | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 82673-191 | NIGHTTIME COLD AND COUGH (DIPHENHYDRAMINE HCL) LIQUID [KINDERFARMS, LLC] | 5 | Current NDC, 2 package rows | 20241003_bfcedca7-f758-4654-822a-5c431906f34d.zip |
| 82673-191 | DAYTIME COUGH CONGESTION NIGHTTIME COLD COUGH (DEXTROMETHORPHAN HBR, GUAIFENESIN, DIPHENHYDRAMINE HCL) KIT [KINDERFARMS, LLC] | 3 | Current NDC | 20240913_f2113abf-c1a3-42a6-a25e-e30a31fcad95.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 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 |
|---|---|---|---|---|
| 1049906 | diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution | PSN | bfcedca7-f758-4654-822a-5c431906f34d | 5 |
| 1049906 | diphenhydramine hydrochloride 2.5 MG/ML Oral Solution | SCD | bfcedca7-f758-4654-822a-5c431906f34d | 5 |
| 1049906 | diphenhydramine HCl 12.5 MG per 5 ML Oral Solution | SY | bfcedca7-f758-4654-822a-5c431906f34d | 5 |
| 1049906 | diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution | SY | bfcedca7-f758-4654-822a-5c431906f34d | 5 |
| 1049906 | diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution | SY | bfcedca7-f758-4654-822a-5c431906f34d | 5 |
| 2683226 | {1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution) / 1 (diphenhydramine hydrochloride 2.5 MG/ML Oral Solution) } Pack | GPCK | f2113abf-c1a3-42a6-a25e-e30a31fcad95 | 3 |
| 2683226 | 1 daytime (dextromethorphan HBr 5 MG / guaiFENesin 100 MG in 5 mL Oral Solution) / 1 nighttime (diphenhydrAMINE hydrochloride 12.5 MG in 5 mL Oral Solution) Pack | PSN | f2113abf-c1a3-42a6-a25e-e30a31fcad95 | 3 |
| 1020138 | dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Solution | PSN | f2113abf-c1a3-42a6-a25e-e30a31fcad95 | 3 |
| 1049906 | diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution | PSN | f2113abf-c1a3-42a6-a25e-e30a31fcad95 | 3 |
| 1020138 | dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution | SCD | f2113abf-c1a3-42a6-a25e-e30a31fcad95 | 3 |
| 1049906 | diphenhydramine hydrochloride 2.5 MG/ML Oral Solution | SCD | f2113abf-c1a3-42a6-a25e-e30a31fcad95 | 3 |
| 2683226 | 1 daytime (dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral Solution) / 1 nighttime (diphenhydramine hydrochloride 12.5 MG per 5 ML Oral Solution) Pack | SY | f2113abf-c1a3-42a6-a25e-e30a31fcad95 | 3 |
| 1020138 | dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Solution | SY | f2113abf-c1a3-42a6-a25e-e30a31fcad95 | 3 |
| 1020138 | dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral Solution | SY | f2113abf-c1a3-42a6-a25e-e30a31fcad95 | 3 |
| 1049906 | diphenhydramine HCl 12.5 MG per 5 ML Oral Solution | SY | f2113abf-c1a3-42a6-a25e-e30a31fcad95 | 3 |
| 1049906 | diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution | SY | f2113abf-c1a3-42a6-a25e-e30a31fcad95 | 3 |
| 1049906 | diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution | SY | f2113abf-c1a3-42a6-a25e-e30a31fcad95 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 82673-191-04 | 82673019104 | 1 BOTTLE, PLASTIC in 1 BOX (82673-191-04) / 118 mL in 1 BOTTLE, PLASTIC | 2024-05-30 | 2027-12-28 | No | No | Historical |