Zapotol Bacitracin
- Product NDC
- 59428-135
- 11-digit product format
- 594280135
- Labeler code
- 59428
- Product ID
- 59428-135_41c89cd8-cf22-fc47-e063-6394a90a07de
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Bacitracin
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Zapatol Corp.
- Application
- M004
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2014-08-06
- Substance
- BACITRACIN
- Active strength
- 500 [USP'U]/g
- Pharmacologic classes
- Decreased Cell Wall Synthesis & Repair [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| N000004-004 | PAREDRINE | HYDROXYAMPHETAMINE HYDROBROMIDE | 1% | SOLUTION/DROPS / OPHTHALMIC | | Approved before 1982 | |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings
Warnings For external use only
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Zapotol Bacitracin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BACITRACIN | 500 [USP'U]/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 58H6RWO52I |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59428-135-14 | Zapotol Bacitracin | 14 g in 1 TUBE | CREAM | 14 | | 5 |
| 59428-135-14 | Zapotol Bacitracin | 1 in 1 PACKAGE | CREAM | 1 | | 5 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59428-135 | ZAPOTOL BACITRACIN (BACITRACIN) CREAM [ZAPATOL CORP.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20241226_c8704895-8819-49ac-8baa-5b97be1d00aa.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 59428-135-14 | 59428013514 | 1 TUBE in 1 PACKAGE (59428-135-14) / 14 g in 1 TUBE | 1 tube | 2016-10-13 | 0000-00-00 | No | No | Current |