Diphenhydramine HCl
- Product NDC
- 0904-6985
- 11-digit product format
- 009046985
- Labeler code
- 0904
- Product ID
- 0904-6985_8e5db62b-075e-4ba2-a139-533be1166006
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine HCl
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-08-27
- Marketing end
- 2027-05-31
- 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
- Diphenhydramine HCl
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 |
|---|---|---|---|---|---|---|
| 0904-6985-16 | Diphenhydramine HCl | 473 mL in 1 BOTTLE, PLASTIC | SOLUTION | 473 | 14 | |
| 0904-6985-20 | Diphenhydramine HCl | 118 mL in 1 BOTTLE, PLASTIC | SOLUTION | 118 | 14 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-6985-16 | ML - Milliliter | 0904-6985 | 6611c1f7-9ef0-4355-bd81-45259ef3f28e | 1 | 2019-10-07 |
| 0904-6985-20 | ML - Milliliter | 0904-6985 | 49dd2649-9d77-4191-9704-1731d6e24956 | 1 | 2020-02-13 |
DailyMed Dashboard NDC Coverage#
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.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049906 | diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution | PSN | 93753885-6add-462c-9df8-b0a1b9ce36c9 | 14 |
| 1049906 | diphenhydramine hydrochloride 2.5 MG/ML Oral Solution | SCD | 93753885-6add-462c-9df8-b0a1b9ce36c9 | 14 |
| 1049906 | diphenhydramine HCl 12.5 MG per 5 ML Oral Solution | SY | 93753885-6add-462c-9df8-b0a1b9ce36c9 | 14 |
| 1049906 | diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution | SY | 93753885-6add-462c-9df8-b0a1b9ce36c9 | 14 |
| 1049906 | diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution | SY | 93753885-6add-462c-9df8-b0a1b9ce36c9 | 14 |
| 1049906 | diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution | PSN | fa12a5a8-bf2d-4991-9d54-9c519e8e04cd | 5 |
| 1049906 | diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution | PSN | d3f769d7-3cbb-4469-bff8-2015619ee115 | 5 |
| 1049906 | diphenhydramine hydrochloride 2.5 MG/ML Oral Solution | SCD | fa12a5a8-bf2d-4991-9d54-9c519e8e04cd | 5 |
| 1049906 | diphenhydramine hydrochloride 2.5 MG/ML Oral Solution | SCD | d3f769d7-3cbb-4469-bff8-2015619ee115 | 5 |
| 1049906 | diphenhydramine HCl 12.5 MG per 5 ML Oral Solution | SY | d3f769d7-3cbb-4469-bff8-2015619ee115 | 5 |
| 1049906 | diphenhydramine HCl 12.5 MG per 5 ML Oral Solution | SY | fa12a5a8-bf2d-4991-9d54-9c519e8e04cd | 5 |
| 1049906 | diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution | SY | d3f769d7-3cbb-4469-bff8-2015619ee115 | 5 |
| 1049906 | diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution | SY | fa12a5a8-bf2d-4991-9d54-9c519e8e04cd | 5 |
| 1049906 | diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution | SY | d3f769d7-3cbb-4469-bff8-2015619ee115 | 5 |
| 1049906 | diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution | SY | fa12a5a8-bf2d-4991-9d54-9c519e8e04cd | 5 |
| 1049906 | diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution | PSN | ebf42e5e-df98-65e5-e053-2a95a90a7ac3 | 1 |
| 1049906 | diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution | PSN | e2532bb9-5182-4017-92b2-e9ece60b4846 | 1 |
| 1049906 | diphenhydramine hydrochloride 2.5 MG/ML Oral Solution | SCD | ebf42e5e-df98-65e5-e053-2a95a90a7ac3 | 1 |
| 1049906 | diphenhydramine hydrochloride 2.5 MG/ML Oral Solution | SCD | e2532bb9-5182-4017-92b2-e9ece60b4846 | 1 |
| 1049906 | diphenhydramine HCl 12.5 MG per 5 ML Oral Solution | SY | ebf42e5e-df98-65e5-e053-2a95a90a7ac3 | 1 |
| 1049906 | diphenhydramine HCl 12.5 MG per 5 ML Oral Solution | SY | e2532bb9-5182-4017-92b2-e9ece60b4846 | 1 |
| 1049906 | diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution | SY | ebf42e5e-df98-65e5-e053-2a95a90a7ac3 | 1 |
| 1049906 | diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution | SY | e2532bb9-5182-4017-92b2-e9ece60b4846 | 1 |
| 1049906 | diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution | SY | ebf42e5e-df98-65e5-e053-2a95a90a7ac3 | 1 |
| 1049906 | diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution | SY | e2532bb9-5182-4017-92b2-e9ece60b4846 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0904-6985-16 | 00904698516 | 473 mL in 1 BOTTLE, PLASTIC (0904-6985-16) | 473 ml | 2019-08-27 | 2027-04-30 | No | No | Current |
| 0904-6985-20 | 00904698520 | 118 mL in 1 BOTTLE, PLASTIC (0904-6985-20) | 118 ml | 2019-08-27 | 2027-05-31 | No | No | Current |