Diphenhydramine Hydrochloride
- Product NDC
- 72789-317
- 11-digit product format
- 727890317
- Labeler code
- 72789
- Product ID
- 72789-317_56d551ca-b3ee-5d72-e063-6294a90af6c8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-04-14
- Marketing end
- 2028-04-30
- Substance
- DIPHENHYDRAMINE HYDROCHLORIDE
- Active strength
- 25 mg/1
- 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 Hydrochloride
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | 25 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| TC2D6JAD40 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1049909 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 879a7804-f3d4-4a3d-bc92-b473499d6c95 | Available on FDA.report |
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 |
|---|---|---|---|---|---|---|
| 72789-317-10 | Diphenhydramine Hydrochloride | 10 in 1 BOTTLE, PLASTIC | CAPSULE | 10 | 6 | |
| 72789-317-12 | Diphenhydramine Hydrochloride | 12 in 1 BOTTLE, PLASTIC | CAPSULE | 12 | 6 | |
| 72789-317-15 | Diphenhydramine Hydrochloride | 15 in 1 BOTTLE, PLASTIC | CAPSULE | 15 | 6 | |
| 72789-317-20 | Diphenhydramine Hydrochloride | 20 in 1 BOTTLE, PLASTIC | CAPSULE | 20 | 6 | |
| 72789-317-30 | Diphenhydramine Hydrochloride | 30 in 1 BOTTLE, PLASTIC | CAPSULE | 30 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 72789-317-10 | EA - Each | 72789-317 | f73d9a2f-5d75-44a8-9b88-a6002474c00f | 1 | 2023-06-06 |
| 72789-317-12 | EA - Each | 72789-317 | 2464e553-8f01-4953-a4b5-43e849652c09 | 1 | 2023-06-06 |
| 72789-317-15 | EA - Each | 72789-317 | 43a8de8b-5675-4f49-905b-f4b4f9b2e1fe | 1 | 2023-06-06 |
| 72789-317-20 | EA - Each | 72789-317 | d8399382-8242-44a4-b03d-72fef2afcbc7 | 1 | 2023-06-06 |
| 72789-317-30 | EA - Each | 72789-317 | f3bbd72e-fe79-4c59-a9b9-412ef69161a0 | 1 | 2023-06-06 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| foster and thrive daytime severe cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Sportpharm LLC | 51e34704-5e6b-4e80-836c-ddbc24a451b2 | 2026-03-06 | Warnings | M012 |
| Medi-First Plus Sinus Decongestant | PHENYLEPHRINE HYDROCHLORIDE | Sportpharm LLC | 20f58b0b-c123-477f-a62c-fa5423e23f93 | 2026-03-06 | Warnings | M012 |
| Nasal Decongestant PE Maximum Strength | PHENYLEPHRINE HCL | Sportpharm LLC | 7f4e8d37-8c6b-4849-b86c-4335a0bcac1c | 2026-03-06 | Warnings | M012 |
| Daytime and Nighttime Cold and Flu Kit | DAYTIME AND NIGHTTIME COLD AND FLU KIT | Allegiant Health | 0533db78-7809-46ea-9998-deb5f6f1d0d9 | 2026-03-06 | Warnings | M012 |
| Nasal Decongestant PE | PHENYLEPHRINE HCL | Better Living Brands, LLC | 0153294d-7f52-4d92-8db8-daeca3e29a3b | 2026-03-06 | Warnings | M012 |
| Mucus DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Meijer Distribution, Inc. | 87cf4f25-b0e9-4f8b-bde3-0d0f26e2120e | 2026-03-06 | Warnings | M012 |
| RYNEX PE | BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL | EDWARDS PHARMACEUTICALS, INC. | 77ae1cf6-b8e5-4f3c-b7bc-e2609a8991ef | 2026-03-05 | Warnings | M012 |
| Childrens Cold and Allergy | BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Best Choice (Valu Merchandisers Company) | 042f9449-4af0-4b15-bb3e-236afeb1e11f | 2026-03-05 | Warnings | M012 |
| Mucus Relief | GUAIFENESIN | Amerisource Bergen | 087a3a0b-8d3f-45ed-8807-0af47b446cac | 2026-03-05 | Warnings | M012 |
| Mucus Relief DM | DEXTROMETHORPHAN HBR 20MG GUAIFENESIN 400MG | NUVICARE LLC | 6c4bc7d1-09d9-4311-8457-a1d47ab02a5a | 2026-03-05 | Warnings | M012 |
| Allergy Relief childrens | DIPHENHYDRAMINE HCL | WALMART INC. | dceb99a9-4aa3-4acc-b632-9a4ba8c87919 | 2026-03-04 | Warnings | M012 |
| AMAZON Childrens Multi Symptom Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | AMAZON.COM SERVICES LLC | 26101105-a6cf-4b51-a639-9d078542fea3 | 2026-03-04 | Warnings | M012 |
| Allergy Relief Childrens | DIPHENHYDRAMINE HCL | Major Pharmaceuticals | 3a976e90-c6af-4414-984e-9987158c9e98 | 2026-03-04 | Warnings | M012 |
| Childrens Allergy | DIPHENHYDRAMINE HCL | Best Choice (Valu Merchandisers Company) | 714e93ec-0aa9-4be2-9311-399e82f148e0 | 2026-03-04 | Warnings | M012 |
| Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Best Choice (Valu Merchandisers Company) | d1131759-dd2e-4c06-bb73-92dd975f5511 | 2026-03-04 | Warnings | M012 |
| AMAZON Maximim Strength Adult Nighttime Cough DM | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | AMAZON.COM SERVICES LLC | 6bbe8cc9-7a60-4476-b5cf-b13c5bebff26 | 2026-03-04 | Warnings | M012 |
| Severe Cold and Flu Daytime, Nighttime | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 5a1dfaf3-370d-4ac7-a72d-a48863a35741 | 2026-03-04 | Warnings | M012 |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Walgreen Company | c5cb09d4-c049-461c-8898-2c5bb6a8a138 | 2026-03-04 | Warnings | M012 |
| Tussin CF | DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCL | WinCo Foods, LLC | 3d96d6d0-8c04-43bb-aed0-4cd00cdf3456 | 2026-03-04 | Warnings | M012 |
| DayTime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | H E B | e2994c0f-add8-4f75-a6d2-24cd2af271e4 | 2026-03-03 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049909 | diphenhydrAMINE HCl 25 MG Oral Capsule | PSN | 879a7804-f3d4-4a3d-bc92-b473499d6c95 | 6 |
| 1049909 | diphenhydramine hydrochloride 25 MG Oral Capsule | SCD | 879a7804-f3d4-4a3d-bc92-b473499d6c95 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 72789-317-10 | 72789031710 | 10 CAPSULE in 1 BOTTLE, PLASTIC (72789-317-10) | 10 capsule | 2023-04-05 | 2028-02-29 | No | No | Historical |
| 72789-317-12 | 72789031712 | 12 CAPSULE in 1 BOTTLE, PLASTIC (72789-317-12) | 12 capsule | 2023-04-05 | 2028-02-29 | No | No | Historical |
| 72789-317-15 | 72789031715 | 15 CAPSULE in 1 BOTTLE, PLASTIC (72789-317-15) | 15 capsule | 2023-04-05 | 2028-02-29 | No | No | Historical |
| 72789-317-20 | 72789031720 | 20 CAPSULE in 1 BOTTLE, PLASTIC (72789-317-20) | 20 capsule | 2023-04-05 | 2028-02-29 | No | No | Historical |
| 72789-317-30 | 72789031730 | 30 CAPSULE in 1 BOTTLE, PLASTIC (72789-317-30) | 30 capsule | 2023-04-05 | 2028-02-29 | No | No | Historical |