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 |
|---|---|---|---|---|---|---|
| Allergy Childrens Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 047102c4-3d03-4b2d-961d-0ac75980147b | 2026-05-06 | Warnings | M012 |
| GOOD SENSE COMBO PACK DAYTIME AND NIGHTTIME | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | L. Perrigo Company | d25f2649-4f8a-4339-8443-faa0b98bdd70 | 2026-05-06 | Warnings | M012 |
| Allergy Relief 4 Hour | CHLORPHENIRAMINE MALEATE | WinCo Foods, LLC | 27e911e1-6d22-4a50-8413-1809c8973cbd | 2026-05-06 | Warnings | M012 |
| ALKA SELTZER COLD Cold Cough Maximum Strength Fast Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 51173330-d537-fb9c-e063-6394a90ae342 | 2026-05-05 | Warnings | M012 |
| Equate daytime severe vaporice cold and flu nighttime severe vapor ice cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | Wal-Mart Stores Inc | 08e74a8d-8e8d-4cda-9adc-ea2ff4068353 | 2026-05-05 | Warnings | M012 |
| GOODSENSE COMBO PACK DAYTIME AND NIGHTTIME | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL | L. Perrigo Company | e42f9e0d-f990-4c33-af43-75acf5d77638 | 2026-05-05 | Warnings | M012 |
| Rugby Mucus and Chest Congestion 541 | GUAIFENESIN | Rugby Laboratories | 76472912-b66f-4bb4-937a-4a589683a78c | 2026-05-04 | Warnings | M012 |
| Sinus Congestion and Pain Daytime Non-Drowsy | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE | H E B | e9dd2d7b-0a19-4a42-b51e-b9914f02406e | 2026-05-04 | Warnings | M012 |
| Sanatos Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Pharmadel LLC | 3dd3ed85-0c0a-8390-e063-6294a90a668e | 2026-05-04 | Warnings | M012 |
| Good Sense Daytime non drowsy cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | L. Perrigo Company | 0122cd34-5817-4af5-a51a-8d176dee0a30 | 2026-05-04 | Warnings | M012 |
| COLD AND FLU RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Safeway | d810a6a9-6112-4e9d-a396-36084b7e110e | 2026-05-04 | Warnings | M012 |
| Doue Vaporizing Chest Rub Cough Suppressant | CAMPHOR, MENTHOL, EUCALYPTUS OIL | ONEST LIMITED | 2089c28b-98fd-4797-8940-b0749d8b5df7 | 2026-05-01 | Warnings | M012 |
| Benadryl Allergy Ultratab | DIPHENHYDRAMINE HYDROCHLORIDE | Savings Distributors LLC | 8d59d121-62a8-c43b-e053-2a95a90a5847 | 2026-05-01 | Warnings | M012 |
| Tylenol Cold Plus Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Savings Distributors LLC | 8e87f8de-f83e-0f8d-e053-2a95a90a8d6a | 2026-05-01 | Warnings | M012 |
| Tylenol Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Savings Distributors LLC | 8eecb3f0-eb5e-e847-e053-2995a90a86bd | 2026-05-01 | Warnings | M012 |
| Sinus Pressure and Congestion Relief PE Maximum Strength | PHENYLEPHRINE HCL | Rite Aid Corporation | fccea3c5-42af-4939-82bc-d9409b75f91f | 2026-05-01 | Warnings | M012 |
| Night Time Cold and Flu original | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Harris Teeter, LLC | cfaf4b3d-fab4-424d-adbe-aaedca58912d | 2026-04-30 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Harris Teeter, LLC | 21e7d323-5b78-43aa-b0fc-34c2a864ab9a | 2026-04-30 | Warnings | M012 |
| daytime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | H E B | ec0b5f4b-b58c-445f-acf1-c7ce301bba64 | 2026-04-30 | Warnings | M012 |
| Mucus Relief DM Max Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN | Harris Teeter, LLC | 098428ae-e87d-4c29-8f02-1590530da58e | 2026-04-29 | 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 |