OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution (Cherry)
- Product NDC
- 87078-421
- 11-digit product format
- 870780421
- Labeler code
- 87078
- Product ID
- 87078-421_4157b5d8-b6fa-c9ce-e063-6394a90a784c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine HCl
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- MEDWISE LIFESCIENCES INC.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-10-06
- 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
- Listing certified through
- 2026-12-31
- 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
- OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution (Cherry)
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | 12.5 mg/5mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| TC2D6JAD40 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1049906 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4157e680-37ac-eb4c-e063-6394a90a2a99 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 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 |
|---|---|---|---|---|---|---|
| 87078-421-52 | OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution (Cherry) | 5 mL in 1 POUCH | SOLUTION | 5 | 1 | |
| 87078-421-52 | OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution (Cherry) | 12 in 1 CARTON | SOLUTION | 12 | 1 |
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 |
|---|---|---|---|---|---|---|
| Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Best Choice (Valu Merchandisers Company) | 64a93715-e7b1-4de1-8099-8ad6c585d517 | 2026-02-24 | Warnings | M012 |
| Cough and Chest Congestion DM Daytime | DEXTROMETHORPHAN HBR, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 86af74c2-9183-4ee9-ad1e-d88dfc8bf47d | 2026-02-24 | Warnings | M012 |
| Cough DM Nighttime | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 39adf23e-76f3-42e1-a9f4-55feb38078e5 | 2026-02-24 | Warnings | M012 |
| Revasol Tussin DM Cough Suppressant Expectorant | DEXTROMETHORPHAN HBR, GUAIFENESIN | Rnv LLC | 4b7fd320-2f39-fa1a-e063-6294a90ada9e | 2026-02-23 | Warnings | M012 |
| Dimetapp Cold and Allergy | BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE | Foundation Consumer Brands | 47317865-4310-4f07-8815-f3130963307d | 2026-02-23 | Warnings | M012 |
| Dimetapp Cold and Cough and Dimetapp Nighttime Cold and Congestion | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND DIPHENHYDRAMINE HYRDOCHLORIDE | Foundation Consumer Brands | 42720fa0-fcdd-4614-80b2-16d0ada345b1 | 2026-02-23 | Warnings | M012 |
| Dimetapp Cold and Cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Foundation Consumer Brands | cc09a8c5-d173-4261-b838-96e6a16e2ff9 | 2026-02-23 | Warnings | M012 |
| Dimetapp Nighttime Cold and Congestion | DIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE | Foundation Consumer Brands | 96a1055f-e831-4f4b-8af3-7a41838c194c | 2026-02-23 | Warnings | M012 |
| Dimetapp Cold and Cough and Nighttime Cold and Congestion | DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE | Foundation Consumer Brands | 1fbe1ce0-5e3e-4af5-a5f1-85ed12ced246 | 2026-02-23 | Warnings | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Better Living Brands, LLC | 0948648c-1c5f-4225-a754-120ca8859f19 | 2026-02-23 | Warnings, Adverse reactions | M012 |
| Revasol Tussin | GUAIFENESIN | Rnv LLC | f66dc593-9023-40e8-9cc3-0380b04b4305 | 2026-02-23 | Warnings | M012 |
| Equate Vaporizing | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Wal-Mart Stores Inc | 3006971b-784c-43fd-91a6-d96876bbf185 | 2026-02-23 | Warnings | M012 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Major Pharmaceuticals | 04e70311-6412-4a20-84e3-f6e26d5f19ab | 2026-02-20 | Warnings | M012 |
| Banophen | DIPHENHYDRAMINE HCL | Major Pharmaceuticals | 7f2b72cc-d4f7-431f-be61-c103cf8c489e | 2026-02-20 | Warnings | M012 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Major Pharmaceuticals | dca04d80-e781-40b1-e053-2995a90a7010 | 2026-02-20 | Warnings | M012 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | LEADER/ Cardinal Health 110, Inc. | e33cbd1d-1848-145a-e053-2995a90aeb50 | 2026-02-20 | Warnings | M012 |
| Vicks DayQuil and Vicks NyQuil Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE | The Procter & Gamble Manufacturing Company | 416c6674-e4aa-6375-e054-00144ff8d46c | 2026-02-20 | Warnings | M012 |
| Head Congestion and Flu Severe Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Rite Aid Corporation | 416080a9-e817-485b-a4ae-6c9d0152c165 | 2026-02-20 | Warnings | M012 |
| Walmart Dye Free Chidrens Allergy Chews | DIPHENHYDRAMINE HCL | WALMART STORES INC | 18436026-b0e4-4481-a647-d735a27d0b00 | 2026-02-19 | Warnings | M012 |
| Vicks DayQuil NyQuil BERRY Kids COLD and COUGH plus | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | The Procter & Gamble Manufacturing Company | 02fbe8b3-49e2-8712-e063-6294a90add50 | 2026-02-19 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049906 | diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution | PSN | 4157e680-37ac-eb4c-e063-6394a90a2a99 | 1 |
| 1049906 | diphenhydramine hydrochloride 2.5 MG/ML Oral Solution | SCD | 4157e680-37ac-eb4c-e063-6394a90a2a99 | 1 |
| 1049906 | diphenhydramine HCl 12.5 MG per 5 ML Oral Solution | SY | 4157e680-37ac-eb4c-e063-6394a90a2a99 | 1 |
| 1049906 | diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution | SY | 4157e680-37ac-eb4c-e063-6394a90a2a99 | 1 |
| 1049906 | diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution | SY | 4157e680-37ac-eb4c-e063-6394a90a2a99 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 87078-421-52 | 87078042152 | 12 POUCH in 1 CARTON (87078-421-52) / 5 mL in 1 POUCH | 12 pouch | 2025-10-17 | No | No | Current |