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 |
|---|---|---|---|---|---|---|
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | FOODHOLD U.S.A., LLC | 508a65ee-42fa-4c0b-b24d-9faac6b0eba7 | 2024-11-24 | Warnings | M012 |
| DG Day Time Cold and Flu Formula and Night Time Cold and Flu Formula | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | PuraCap Pharmaceutical LLC | cb68eef0-b027-4bf1-b78f-f31844a8c06c | 2024-11-22 | Warnings | M012 |
| Benadryl | DIPHENHYDRAMINE HYDROCHLORIDE | Lil' Drug Store Products, Inc. | de2a64ce-c169-4162-b79e-d3809bea2147 | 2024-11-22 | Warnings | M012 |
| 12 Hour Nasal Decongestant Extra Moisturizing | NASAL SPRAY | WinCo Foods LLC | 13fbde45-958c-455f-b766-f6a34342ee95 | 2024-11-21 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | a01abac3-c13e-40f2-ae98-34bd6c9b7504 | 2024-11-21 | Warnings | M012 |
| DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 9fc3fb4b-8906-4f4b-bc5d-9cf1e38fd6c6 | 2024-11-21 | Warnings | M012 |
| Dextromethorphan HBr 15 mg | DEXTROMETHORPHAN HBR | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 028b025e-2dde-4bef-ba7b-61774e855b4b | 2024-11-21 | Warnings | M012 |
| Daytime Severe Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | PuraCap Pharmaceutical LLC | 856cb3c3-8f32-4285-8c13-25f01779a31a | 2024-11-21 | Warnings | M012 |
| Night Time Severe Cold and Flu Relief | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE | PuraCap Pharmaceutical LLC | 3375a059-2939-438e-92b5-a7f1952bbb22 | 2024-11-21 | Warnings | M012 |
| NiteTime Cold/Flu, Multi-Symptom Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Wal-Mart Stores Inc | 9033bf94-f444-4488-b717-050d04dee388 | 2024-11-21 | Warnings | M012 |
| Day and Night Sinus Relief Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores, Inc. | 4b554ce8-9a6a-444f-b5ea-63359bbc0653 | 2024-11-21 | Warnings | M012 |
| Day Severe Cold and Night Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores, Inc. | 7492b381-9eca-4b07-b356-63fdaea14f81 | 2024-11-21 | Warnings | M012 |
| Severe sinus Congestion Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | FOODHOLD U.S.A., LLC | e173bec9-14df-4535-a023-47d8cda8d4ec | 2024-11-21 | Warnings | M012 |
| COLD FLU and SORE THROAT RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | FOODHOLD U.S.A., LLC | 1161e5dc-0677-4fb9-964f-971a508098b6 | 2024-11-21 | Warnings | M012 |
| Night Time Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Retail Business Services, LLC | fc8c70d6-6be5-4f12-84b0-125fc82149ec | 2024-11-21 | Warnings | M012 |
| 12 Hour Original Nasal Decongestant | NASAL SPRAY | WinCo Foods LLC | b3b6065a-56da-45e9-b89d-f6553bc181c9 | 2024-11-21 | Warnings | M012 |
| Family Wellness Oxymetazoline Sinus Severe | OXYMETAZOLINE | FAMILY DOLLAR (Family Wellness) | 13237d31-c60a-49f8-9b96-4414cf766a08 | 2024-11-21 | Warnings | M012 |
| DayTime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 5b55d1df-275b-40d8-bde3-fc43313b7eb3 | 2024-11-20 | Warnings | M012 |
| Halls Green Apple | MENTHOL | Mondelez Global LLC | 1bb8dcb2-c3a8-a64e-e063-6294a90ae4a2 | 2024-11-20 | Warnings | M012 |
| Halls Blueberry | MENTHOL | Mondelez Global LLC | 275a6935-ea44-486e-e063-6394a90ae19a | 2024-11-20 | 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 |