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 |
|---|---|---|---|---|---|---|
| dg health adult tussin | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Dolgencorp Inc | 81f12484-ddf7-49c6-b530-3a81d62ab40d | 2024-11-10 | Warnings | M012 |
| careone tussin dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Retail Business Services, LLC | 230fa1ea-ae7c-425e-8447-79a90c96ae9e | 2024-11-10 | Warnings | M012 |
| good sense tussin dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | L. Perrigo Company | cb8a1d81-b1a3-4217-b157-9e5d398f202d | 2024-11-09 | Warnings | M012 |
| PhysiciansCare Allergy Antihistamine | DIPHENHYDRAMINE HYDROCHLORIDE | Acme United Corporation | 5e31b1ff-291f-7b8c-e053-2a91aa0aedbc | 2024-11-09 | Warnings | M012 |
| Duraflu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCL | Poly Pharmaceuticals, Inc. | 55fffc1d-8449-4c28-a391-c6f60dd85622 | 2024-11-09 | Warnings | M012 |
| Poly-Vent IR | GUAIFENESIN AND PSEUDOEPHEDRINE HCL | Poly Pharmaceuticals, Inc. | ce0d8c45-446a-4df4-a36b-5000ba69d30d | 2024-11-09 | Warnings | M012 |
| basic care tussin dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Amazon.com Services LLC | 306d5914-03ed-410a-9345-c54ba604e991 | 2024-11-09 | Warnings | M012 |
| care one nasal original | OXYMETAZOLINE HYDROCHLORIDE | American Sales Company | a0c35e06-c9e9-438e-8224-d4760b6e2aff | 2024-11-09 | Warnings | M012 |
| adult tussin dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Walgreen Company | 34174507-cf2e-4ed4-85ec-f915d4b910df | 2024-11-08 | Warnings | M012 |
| Childrens Benadryl Chewables | DIPHENHYDRAMINE HYDROCHLORIDE | Kenvue Brands LLC | b08f71d8-a06c-41ba-8ed1-fbc41dbc1919 | 2024-11-08 | Warnings | M012 |
| SUDAFED PE SINUS CONGESTION | DIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | a38fdfb8-db89-487f-9b68-aa9152b91f5f | 2024-11-08 | Warnings | M012 |
| SUDAFED Sinus Congestion | PSEUDOEPHEDRINE HYDROCHLORIDE | Kenvue Brands LLC | c05d7e27-6821-468f-b27d-9c0b02a07b0f | 2024-11-08 | Warnings | M012 |
| Benadryl | DIPHENHYDRAMINE HYDROCHLORIDE | Kenvue Brands LLC | 2884d2dc-2d4a-4ca6-ab73-688a80b428eb | 2024-11-08 | Warnings | M012 |
| Extra Strength TYLENOL Cold plus Flu Multi-Action Day/Night | ACETAMINOPHEN, PSEUDOEPHEDRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND CHLORPHENIRAMINE MALEATE | Kenvue Brands LLC | 712ba011-79aa-469b-9f0f-04a0b4b705bd | 2024-11-08 | Warnings | M012 |
| SUDAFED PE Pressure Plus Pain | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 8538c291-9ce9-4866-b268-f4cbdb52f5bd | 2024-11-08 | Warnings | M012 |
| Childrens Sudafed Nasal Decongestant | PSEUDOEPHEDRINE HYDROCHLORIDE | Kenvue Brands LLC | 52e9307b-ad38-4f65-bb2f-4fa262e82010 | 2024-11-08 | Warnings | M012 |
| Benadryl Allergy Plus Congestion | DIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 685b51d3-cc25-47b2-ac8a-368924f43137 | 2024-11-08 | Warnings | M012 |
| Sudafed PE Sinus Pressure Plus Pain | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 60183922-bfd3-4377-884a-51b2f0a4c93a | 2024-11-08 | Warnings | M012 |
| Sudafed PE Sinus Congestion | PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 2ca08917-1a75-4365-8520-c083e6a4225a | 2024-11-08 | Warnings | M012 |
| SUDAFED PE Head Congestion Plus Mucus | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | f0739186-41b9-4761-adf7-08101b30a18e | 2024-11-08 | 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 |