Calamine
- Product NDC
- 82645-900
- 11-digit product format
- 826450900
- Labeler code
- 82645
- Product ID
- 82645-900_0d1cd55e-cd93-6e7e-e063-6294a90ae7a5
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Calamine 8% and Zinc Oxide 8%
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Pharma Nobis, LLC
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 1998-03-25
- Substance
- ZINC OXIDE
- Active strength
- 160 mg/mL
- Pharmacologic classes
- Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Calamine
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ZINC OXIDE | 160 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| SOI2LOH54Z | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 617954 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e42f0bd6-3ad3-7e07-e053-2995a90a564a | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 82645-900-96 | Calamine | 177 mL in 1 BOTTLE, PLASTIC | LOTION | 177 | 2 |
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Nail Fungus Repairing Liquid | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 57b8b3e5-88be-3a91-e063-6294a90a05be | 2026-07-28 | Warnings | M016 |
| DERMFREE INSECT BITE RELIEF | SODIUM BICARBONATE 5% INSECT BITE RELIEF | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 5794886c-0d74-9f35-e063-6394a90a27d8 | 2026-07-27 | Warnings | M016 |
| OKeeffes Lip Repair SEAL and HEAL | PETROLATUM | The Gorilla Glue Company/O'Keeffe's Company | 55f66f54-da39-76c7-e063-6394a90aeda9 | 2026-07-27 | Warnings | M016 |
| Boo Boo Magic Diaper Rash Creamy | ZINC OXIDE | Alboo Brands LLC | 5114aff8-adde-e610-e063-6294a90a77ea | 2026-07-27 | Warnings | M016 |
| PrevaDRM Vitamin Repair | SKIN PROTECTANT | Sion Brands LLC | 579e4639-a742-1901-e063-6294a90a2d45 | 2026-07-27 | Warnings | M016 |
| Hello Bello Diaper Rash Cream | ZINC OXIDE | Topiderm, Inc. | e158ba31-e159-4624-a490-fe70baaf4a39 | 2026-07-24 | Warnings | M016 |
| Gethorey Vein Target Microneedle Patch | ALLANTOIN 2% VEIN TARGET MICRONEEDLE PATCH | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 57593145-a874-15d9-e063-6294a90a77d9 | 2026-07-24 | Warnings | M016 |
| Fresh Scent PROTECTIVE BABY | ZINC OXIDE | CVS Pharmacy, Inc. | 3f33c62c-43ec-4576-a24d-bd5de07e74d2 | 2026-07-23 | Warnings | M016 |
| Estriol Cream | ESTRIOL | Guangxi Keyun E-commerce Co., Ltd. | 4deadcb6-0d46-bdd7-e063-6294a90a26d7 | 2026-07-23 | Warnings | M016 |
| DERMFREE Vein Target Microneedle Patch | ALLANTOIN 1% VEIN TARGET MICRONEEDLE PATCH | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 57449e29-ec46-9c30-e063-6394a90a7b4a | 2026-07-23 | Warnings | M016 |
| Baby Vitamin A and D | LANOLIN 15.5%, PETROLATUM 53.4% | Walgreen Company | 25a125ea-6f9f-310c-e063-6394a90acef2 | 2026-07-22 | Warnings | M016 |
| First Aid A and D | LANOLIN 15.5%, PETROLATUM 53.4% | Walgreen Company | 25a319d0-d39a-5ff0-e063-6394a90a671d | 2026-07-22 | Warnings | M016 |
| Calamine | CALAMINE AND ZINC OXIDE | Marie's Original Formulas LLC | 57110309-9a3d-025f-e063-6394a90a015a | 2026-07-22 | Warnings | M016 |
| Dermasporin | LANOLIN | Marie's Original Formulas LLC | 562f40aa-eeec-2b7c-e063-6294a90ad68d | 2026-07-22 | Warnings | M016 |
| CAREALL Vitamin A and D | PETROLATUM | New World Imports, Inc | ef89a68a-74c1-4c42-8078-b7a208ace0de | 2026-07-22 | Warnings | M016 |
| Dermact | LANOLIN | Marie's Original Formulas LLC | 57121dbe-e886-a562-e063-6294a90a367f | 2026-07-22 | Warnings | M016 |
| Universal WITCH HAZEL | WITCH HAZEL | Universal Distribution Center LLC | 7e0b56ef-fa41-4862-b387-5b58d81d67d4 | 2026-07-22 | Warnings | M016 |
| Aveeno Soothing Bath Treatment | OATMEAL | Kenvue Brands LLC | 0c410b8e-025f-477c-afac-6e2e9ac88f7d | 2026-07-21 | Warnings | M016 |
| DERMFREE SCAR SHEETS | SILICONE GEL 1% SCAR SHEETS | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a4ce316-4b92-7e81-e063-6294a90af6db | 2026-07-21 | Warnings | M016 |
| DERMFREE VARICOSE VEINS | DIMETHICONE 3% VARICOSE VEINS | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a5a2d1d-9e84-18eb-e063-6394a90a97ee | 2026-07-21 | Warnings | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 617954 | calamine 8 % / zinc oxide 8 % Topical Lotion | PSN | e42f0bd6-3ad3-7e07-e053-2995a90a564a | 2 |
| 617954 | calamine 80 MG/ML / zinc oxide 80 MG/ML Topical Lotion | SCD | e42f0bd6-3ad3-7e07-e053-2995a90a564a | 2 |
| 617954 | calamine 8 % / zinc oxide 8 % Topical Lotion | SY | e42f0bd6-3ad3-7e07-e053-2995a90a564a | 2 |
| 617954 | Calamine 80 MG/ML / ZNO 80 MG/ML Topical Lotion | SY | e42f0bd6-3ad3-7e07-e053-2995a90a564a | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 82645-900-96 | 82645090096 | 177 mL in 1 BOTTLE, PLASTIC (82645-900-96) | 177 ml | 2017-11-13 | 0000-00-00 | No | No | Current |