Diphenhydramine HCl
- Product NDC
- 0904-7559
- 11-digit product format
- 009047559
- Labeler code
- 0904
- Product ID
- 0904-7559_45b07e82-0ce9-492f-8303-65c992c7dc32
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- diphenhydramine hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-07-15
- Substance
- DIPHENHYDRAMINE HYDROCHLORIDE
- Active strength
- 25 mg/10mL
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Diphenhydramine HCl
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | 25 mg/10mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | TC2D6JAD40 |
| Rxcui | 1049906 |
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 |
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 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 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 6084a4f4-5437-c9a5-caec-5361ee075a59 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
| 90c5639a-61b0-88d6-ddcf-21888e94869a | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0904-7559-66 | Diphenhydramine HCl | 10 mL in 1 CUP, UNIT-DOSE | SOLUTION | 10 | 2 | |
| 0904-7559-72 | Diphenhydramine HCl | 10 in 1 CASE | SOLUTION | 10 | 2 | |
| 0904-7559-72 | Diphenhydramine HCl | 10 in 1 TRAY | SOLUTION | 10 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-7559-66 | ML - Milliliter | 0904-7559 | 7d00a455-73c9-4a2e-b44f-ad1385554e67 | 1 | 2025-09-12 |
| 0904-7559-72 | ML - Milliliter | 0904-7559 | e16d02ce-aa1f-40b5-bf7b-d8daa291946b | 1 | 2025-09-12 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049906 | diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution | PSN | 1b591e27-b00b-41c8-9fe9-c633aba09134 | 2 |
| 1049906 | diphenhydramine hydrochloride 2.5 MG/ML Oral Solution | SCD | 1b591e27-b00b-41c8-9fe9-c633aba09134 | 2 |
| 1049906 | diphenhydramine HCl 12.5 MG per 5 ML Oral Solution | SY | 1b591e27-b00b-41c8-9fe9-c633aba09134 | 2 |
| 1049906 | diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution | SY | 1b591e27-b00b-41c8-9fe9-c633aba09134 | 2 |
| 1049906 | diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution | SY | 1b591e27-b00b-41c8-9fe9-c633aba09134 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0904-7559-66 | 00904755966 | 10 mL in 1 CUP, UNIT-DOSE | 10 ml | Historical | |||
| 0904-7559-72 | 00904755972 | 10 TRAY in 1 CASE (0904-7559-72) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0904-7559-66) | 10 tray | 2025-08-01 | No | No | Historical |