Diphenhydramine Hydrochloride
- Product NDC
- 71335-1366
- 11-digit product format
- 713351366
- Labeler code
- 71335
- Product ID
- 71335-1366_a6916952-e557-4a8f-8d8f-d893991f1e0a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- part341
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2007-05-24
- Marketing end
- 0000-00-00
- Substance
- DIPHENHYDRAMINE HYDROCHLORIDE
- Active strength
- 50 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
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 product | product | 71335-1366 | D | Discontinued by firm | 2026-10-15 | ||
| excluded package | package | 71335-1366 | 71335-1366-0 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 71335-1366 | 71335-1366-1 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 71335-1366 | 71335-1366-2 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 71335-1366 | 71335-1366-3 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 71335-1366 | 71335-1366-4 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 71335-1366 | 71335-1366-5 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 71335-1366 | 71335-1366-6 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 71335-1366 | 71335-1366-7 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 71335-1366 | 71335-1366-8 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 71335-1366 | 71335-1366-9 | D | Discontinued by firm | 2026-10-15 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-1366-5 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-1366-0 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-1366-6 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-1366-2 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-1366-9 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-1366-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-1366-8 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-1366-4 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-1366-3 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-1366-7 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-1366-5 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-1366-0 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-1366-6 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-1366-2 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-1366-9 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-1366-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-1366-8 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-1366-4 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-1366-3 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-1366-7 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-1366-5 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-1366-0 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-1366-6 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-1366-2 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-1366-9 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-1366-1 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-1366-8 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-1366-4 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-1366-3 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71335-1366-7 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-1366-5 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-1366-0 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-1366-6 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-1366-2 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-1366-9 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-1366-1 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-1366-8 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-1366-4 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-1366-3 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71335-1366-7 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-1366-5 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-1366-0 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-1366-6 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-1366-2 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-1366-9 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-1366-1 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-1366-8 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-1366-4 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-1366-3 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71335-1366-7 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 71335-1366-5 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 71335-1366-0 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 71335-1366-6 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 71335-1366-2 | cdf11ea48f46… | ba0047e9e063… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 71335-1366-0 | 71335136600 | 12 CAPSULE in 1 BOTTLE (71335-1366-0) | 12 capsule | 2007-05-24 | 0000-00-00 | No | No | Current |
| 71335-1366-1 | 71335136601 | 15 CAPSULE in 1 BOTTLE (71335-1366-1) | 15 capsule | 2007-05-24 | 0000-00-00 | No | No | Current |
| 71335-1366-2 | 71335136602 | 20 CAPSULE in 1 BOTTLE (71335-1366-2) | 20 capsule | 2007-05-24 | 0000-00-00 | No | No | Current |
| 71335-1366-3 | 71335136603 | 30 CAPSULE in 1 BOTTLE (71335-1366-3) | 30 capsule | 2007-05-24 | 0000-00-00 | No | No | Current |
| 71335-1366-4 | 71335136604 | 10 CAPSULE in 1 BOTTLE (71335-1366-4) | 10 capsule | 2007-05-24 | 0000-00-00 | No | No | Current |
| 71335-1366-5 | 71335136605 | 6 CAPSULE in 1 BOTTLE (71335-1366-5) | 6 capsule | 2007-05-24 | 0000-00-00 | No | No | Current |
| 71335-1366-6 | 71335136606 | 100 CAPSULE in 1 BOTTLE (71335-1366-6) | 100 capsule | 2007-05-24 | 0000-00-00 | No | No | Current |
| 71335-1366-7 | 71335136607 | 90 CAPSULE in 1 BOTTLE (71335-1366-7) | 90 capsule | 2007-05-24 | 0000-00-00 | No | No | Current |
| 71335-1366-8 | 71335136608 | 60 CAPSULE in 1 BOTTLE (71335-1366-8) | 60 capsule | 2007-05-24 | 0000-00-00 | No | No | Current |
| 71335-1366-9 | 71335136609 | 2 CAPSULE in 1 BOTTLE (71335-1366-9) | 2 capsule | 2007-05-24 | 0000-00-00 | No | No | Current |