Childrens Allergy
- Product NDC
- 55301-092
- 11-digit product format
- 553010092
- Labeler code
- 55301
- Product ID
- 55301-092_df086eb6-6369-4a7b-9341-953933304f97
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine Hydrochloride
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- AAFES/Your Military Exchanges
- Application
- part341
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2015-09-30
- Marketing end
- 2023-12-29
- Substance
- DIPHENHYDRAMINE HYDROCHLORIDE
- Active strength
- 13 mg/5mL
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 | 55301-092 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 55301-092 | 55301-092-04 | D | Discontinued by firm | 2026-10-05 |
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 |
|---|---|---|---|---|---|
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 55301-092-04 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 55301-092-04 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 55301-092-04 | 557ba5c1ecfa… | 9c80585c8c6e… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 55301-092-04 | 55301009204 | 1 BOTTLE, PLASTIC in 1 BOX (55301-092-04) > 118 mL in 1 BOTTLE, PLASTIC | 2015-09-30 | 0000-00-00 | No | No | Current |