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 |
|---|---|---|---|---|---|---|
| Sugar Free Honey-Lemon Fishermans Friend Menthol Cough Suppressant | MENTHOL | Lofthouse of Fleetwood, Ltd. | 87ebb4d9-78d7-1c87-e053-2a95a90adb7d | 2025-03-27 | Warnings | M012 |
| REVASOL CHILDRENS ALLERGY | DIPHENHYDRAMINE HCL | Rnv LLC | 3143137f-ef42-5358-e063-6394a90a8ed1 | 2025-03-26 | Warnings | M012 |
| Rompe Pecho SF FLU | DEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE | Efficient Laboratories Inc | bc10695a-9664-4ce3-82bb-820da06129fa | 2025-03-26 | Warnings | M012 |
| SUPRESS-PE Pediatric | GUIAFENESIN, PHENYLEPHRINE HCL | Kramer Novis | a474171d-5c29-4a80-9d37-00613796211a | 2025-03-26 | Warnings | M012 |
| Guaifenesin DM | DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN | Innovida Pharmaeutique Corporation | dd3f806b-2470-4055-94e1-18adac811025 | 2025-03-25 | Warnings | M012 |
| Foster and Thrive childrens cold cough relief dm | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Strategic Sourcing Services LLC | 38b710e3-1d01-4ff4-a6b6-44936f277f49 | 2025-03-25 | Warnings | M012 |
| Revasol Tussin DM Max with Honey | DEXTROMETHORPHAN HBR AND GUAIFENESIN | Rnv LLC | 30da9255-c93a-84d6-e063-6394a90a7c2a | 2025-03-21 | Warnings | M012 |
| REVASOL NIGHTTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE | Rnv LLC | 30dfd8f7-4cc6-d4f2-e063-6394a90aa9c9 | 2025-03-21 | Warnings | M012 |
| Chest Congestion Relief | GUAIFENESIN | Meijer, Inc. | 261a79b3-5704-76f2-e063-6394a90a5ac6 | 2025-03-20 | Warnings | M012 |
| Rompe Tos X Children | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | OPMX LLC | 05cc932d-b412-0710-e063-6394a90a87f6 | 2025-03-19 | Warnings | M012 |
| Rompe Tos X Adults | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | OPMX LLC | 05abb2db-d22e-90b5-e063-6294a90ace3f | 2025-03-19 | Warnings | M012 |
| Sinus Head Congestion | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE | VIVUNT PHARMA LLC | 30a07773-bd6f-b9f2-e063-6394a90ab8aa | 2025-03-18 | Warnings | M012 |
| Halls Sugar Free Black Cherry | MENTHOL | Mondelez Global LLC | bd2a311a-bf0c-4365-af9b-76675c243b22 | 2025-03-16 | Warnings | M012 |
| Medicated Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | TARGET CORPORATION | fbca9627-5e12-048a-e053-6294a90a6e0f | 2025-03-15 | Warnings | M012 |
| Medicated Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | DOLGENCORP, INC. | 0655688e-7c42-507f-e063-6294a90ae498 | 2025-03-15 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | CVS PHARMACY, INC | 1b8d5494-1fcf-4cd0-acc0-34f17d577bd7 | 2025-03-14 | Warnings | M012 |
| Ultra Concentrated Daytime COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | PuraCap Pharmaceutical LLC | 300b2357-933b-fe9a-e063-6294a90aa4b9 | 2025-03-11 | Warnings | M012 |
| Ultra Concentrated Nighttime COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | PuraCap Pharmaceutical LLC | 300bf27f-744f-7366-e063-6394a90acbcb | 2025-03-11 | Warnings | M012 |
| Daytime COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | PuraCap Pharmaceutical LLC | 300c7c7b-ea0b-3650-e063-6294a90a65e8 | 2025-03-11 | Warnings | M012 |
| Rompe Pecho Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | EFFICIENT LABORATORIES INC | 2ec319a8-92bf-4552-86dd-37cbce18980f | 2025-03-11 | 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 |