Nighttime Sleep Aid
- Product NDC
- 72476-034
- 11-digit product format
- 724760034
- Labeler code
- 72476
- Product ID
- 72476-034_5ab0dc58-4063-42aa-b9e1-ac5c55c74cb1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine HCl
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Care One (Retail Business Services, LLC.)
- Application
- part341
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2019-06-30
- Marketing end
- 0000-00-00
- Substance
- DIPHENHYDRAMINE HYDROCHLORIDE
- Active strength
- 50 mg/30mL
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 | 72476-034 | D | Discontinued by firm | 2026-10-15 | ||
| excluded package | package | 72476-034 | 72476-034-06 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 72476-034 | 72476-034-12 | 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 | 72476-034-12 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 72476-034-06 | 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 | 72476-034-12 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 72476-034-06 | f5e01cc5f278… | a2eaf40c39c3… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 72476-034-06 | 72476003406 | 177 mL in 1 BOTTLE, PLASTIC (72476-034-06) | 177 ml | 2019-06-30 | 0000-00-00 | No | No | Current |
| 72476-034-12 | 72476003412 | 355 mL in 1 BOTTLE, PLASTIC (72476-034-12) | 355 ml | 2019-06-30 | 0000-00-00 | No | No | Current |