Diphenhydramine Hydrochloride
- Product NDC
- 0363-9835
- 11-digit product format
- 003639835
- Labeler code
- 0363
- Product ID
- 0363-9835_5c90c46c-9450-cc10-e063-6294a90ace65
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Walgreen Company
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-09-07
- Substance
- DIPHENHYDRAMINE HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 0363-9835 | 0363-9835-01 | D | Discontinued by firm | 2026-10-23 | |
| excluded package | package | 0363-9835 | 0363-9835-02 | D | Discontinued by firm | 2026-10-23 | |
| excluded package | package | 0363-9835 | 0363-9835-06 | D | Discontinued by firm | 2026-10-23 |
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
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | 25 mg/1 |
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 |
|---|---|---|---|---|---|---|
| 0363-9835-01 | Diphenhydramine Hydrochloride | 100 in 1 BOTTLE | CAPSULE | 100 | 4 | |
| 0363-9835-01 | Diphenhydramine Hydrochloride | 1 in 1 CARTON | CAPSULE | 1 | 4 | |
| 0363-9835-02 | Diphenhydramine Hydrochloride | 600 in 1 BOTTLE | CAPSULE | 600 | 4 | |
| 0363-9835-06 | Diphenhydramine Hydrochloride | 365 in 1 BOTTLE | CAPSULE | 365 | 4 |
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 |
|---|---|---|---|---|---|---|
| CHILDRENS COLD AND COUGH | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | H E B | 08f4785a-c628-4e9b-9412-b2a817f9be60 | 2025-11-07 | Warnings | M012 |
| G-TUSICOF | DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE | Kramer Novis | d169585f-b4f4-4831-8c71-e1533ae7e7c4 | 2025-11-07 | Warnings | M012 |
| Cold and Flu Relief | ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL | QUALITY CHOICE (Chain Drug Marketing Association) | 1d512053-7a54-4691-a657-77da4c627cb8 | 2025-11-07 | Warnings | M012 |
| Allergy and Headache | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | dc249163-26dd-42ca-b423-2f16299f2d65 | 2025-11-07 | Warnings | M012 |
| Sinus Congestion | PSEUDOEPHEDRINE HCL | Chain Drug Marketing Association, Inc. | 9744d04d-298d-4acd-9470-db9e7f2901e7 | 2025-11-07 | Warnings | M012 |
| Daytime, Nighttime Severe Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | c3b7fab1-f7fe-41be-a1c4-7ba4ba23c159 | 2025-11-07 | Warnings | M012 |
| Severe Cold and Flu Relief Daytime/Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL | ARMY AND AIR FORCE EXCHANGE SERVICE | 1c0c562a-68dc-4e9a-b8f3-ae70b9a4948e | 2025-11-07 | Warnings | M012 |
| Vicks DayQuil HIGH BLOOD PRESSURE COLD and FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | The Procter & Gamble Manufacturing Company | ff0bffee-9a36-8246-e053-6294a90a86c7 | 2025-11-06 | Warnings | M012 |
| Xlear Nasal Decongestant | NASAL SPRAY | Xlear Inc. | 1c1db71a-47d0-42ac-8cbe-95e76dca185f | 2025-11-06 | Warnings | M012 |
| Robitussin Honey Cough DM Day Night Value Pack | DEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATE | Haleon US Holdings LLC | 1bbd0157-06e6-4a3b-bac9-91ac879ba089 | 2025-11-06 | Warnings | M012 |
| ValuMeds Nasal Decongestant Phenylephrine HCl | PHENYLEPHRINE HYDROCHLORIDE | Cabinet Health P.B.C. | 21676b0c-6be2-464c-ae91-92e5f0d0087d | 2025-11-06 | Warnings | M012 |
| COLD AND FLU SEVERE Daytime, Nighttime | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Meijer Distribution, Inc. | 04715af5-e861-496c-834a-233eb7312556 | 2025-11-06 | Warnings | M012 |
| Severe Allergy Plus Sinus Headache | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Wal-Mart Stores Inc | 1a1f41c4-5430-4cff-873e-6547dadc8779 | 2025-11-06 | Warnings | M012 |
| Target Overnight Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL | TARGET CORPORATION | 05e944d5-3473-4d8c-8df4-2ffc7474e9fa | 2025-11-05 | Warnings | M012 |
| Target Cough plus Chest Congestion DM Max with Honey | DEXTROMETHORPHAN HBR, GUAIFENESIN | TARGET CORPORATION | e36f179e-5aed-4fee-8b0a-767bf3590752 | 2025-11-05 | Warnings | M012 |
| Target Maximum Strength Cold Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | TARGET CORPORATION | 1d3ad31f-ef4d-45ba-a6e3-13d66b51d1d2 | 2025-11-05 | Warnings | M012 |
| Up and Up maximum Strength fast mucus relief Severe Congestion and Cough | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Target Corporation | f007beaa-b108-46d5-8a98-853f011a8e2e | 2025-11-05 | Warnings | M012 |
| Target Childrens Cough Relief | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | TARGET CORPORATION | 975e157a-8f8d-41ad-b55b-9f9100188ccd | 2025-11-05 | Warnings | M012 |
| Target Maximum Strength Cold Flu and Sore Throat Overnight Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL AND TRIPROLIDINE HCL | TARGET CORPORATION | 6e94fdab-27ea-4c0f-a91c-735ce697304b | 2025-11-05 | Warnings | M012 |
| Target Dye Free Childrens Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Target Corporation | 76299495-7259-4bbe-8393-7eabfe22715a | 2025-11-05 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049909 | diphenhydrAMINE HCl 25 MG Oral Capsule | PSN | beb34c94-8370-e97d-e053-2995a90a59cc | 4 |
| 1049909 | diphenhydramine hydrochloride 25 MG Oral Capsule | SCD | beb34c94-8370-e97d-e053-2995a90a59cc | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0363-9835-01 | 00363983501 | 1 BOTTLE in 1 CARTON (0363-9835-01) > 100 CAPSULE in 1 BOTTLE | 1 bottle | 2021-09-07 | 0000-00-00 | No | No | Current |
| 0363-9835-02 | 00363983502 | 600 CAPSULE in 1 BOTTLE (0363-9835-02) | 600 capsule | 2022-05-05 | 0000-00-00 | No | No | Current |
| 0363-9835-06 | 00363983506 | 365 CAPSULE in 1 BOTTLE (0363-9835-06) | 365 capsule | 2021-10-01 | 0000-00-00 | No | No | Current |