Calamine
- Product NDC
- 85786-703
- 11-digit product format
- 857860703
- Labeler code
- 85786
- Product ID
- 85786-703_4ecd0add-11ca-cf3b-e063-6394a90adff6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Calamine 8%, Zinc Oxide 8%
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Farmacias De Similares TX LLC
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-04-06
- Substance
- FERRIC OXIDE RED; ZINC OXIDE
- Active strength
- 80; 80 mg/mL; mg/mL
- Pharmacologic classes
- Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Calamine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FERRIC OXIDE RED | 80 mg/mL |
| ZINC OXIDE | 80 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1K09F3G675, SOI2LOH54Z |
| Rxcui | 617954 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 85786-703-06 | Calamine | 177 mL in 1 BOTTLE, PLASTIC | LOTION | 177 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 85786-703-06 | 85786070306 | 177 mL in 1 BOTTLE, PLASTIC (85786-703-06) | 177 ml | 2026-04-06 | No | No | Historical |