Controlling balm with tea tree oil
- Product NDC
- 35192-016
- Requested package NDC
- 35192-016-05
- 11-digit product format
- 351920016
- Labeler code
- 35192
- Product ID
- 35192-016_ef67a81a-21a3-2285-e053-2995a90ad263
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- SALICYLIC ACID
- Dosage form
- EMULSION
- Route
- TOPICAL
- Labeler
- CA-BOTANA INTERNATIONAL
- Application
- part358H
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2014-11-09
- Marketing end
- 0000-00-00
- Substance
- SALICYLIC ACID
- Active strength
- 0 mg/29.6mg
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 package | package | 35192-016 | 35192-016-05 | D | Discontinued by firm | 2026-10-05 |
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 | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 35192-016-05 | 35192001605 | 29.4 mg in 1 TUBE (35192-016-05) | 29.4 mg | 2017-11-02 | 0000-00-00 | No | No | Current |