Calamine
- Product NDC
- 82645-418
- 11-digit product format
- 826450418
- Labeler code
- 82645
- Product ID
- 82645-418_52b97551-89e2-c3b8-e063-6394a90af476
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Calamine and Zinc Oxide
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Pharma Nobis, LLC
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-05-16
- 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
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Calamine
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| FERRIC OXIDE RED | 80 mg/mL |
| ZINC OXIDE | 80 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1K09F3G675 | Internal UNII lookup |
| SOI2LOH54Z | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 617954 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| fbcfa541-beda-06de-e053-6294a90a9298 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 82645-418-96 | Calamine | 177 mL in 1 BOTTLE, PLASTIC | LOTION | 177 | 3 |
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 |
|---|---|---|---|---|---|---|
| Pediadermics eczema 3 | COLLOIDAL OATMEAL, DIMETHICONE | Renu Laboratories, LLC | af861f0b-4387-6861-e053-2995a90a8bfa | 2025-12-02 | Warnings | M016 |
| Flexitol Face and Eyelid Eczema | OATMEAL | LaCorium Health USA Inc. | f5b24f9c-1a77-4dc3-b7fd-ccad7b06ee65 | 2025-12-02 | Warnings | M016 |
| ProCure HydroShield | PETROLATUM 41% | Twin Med LLC | 3d36e664-ac10-72eb-e063-6294a90a49c4 | 2025-12-01 | Warnings | M016 |
| ProCure Vitamin A and D | WHITE PETROLATUM 93.4% | Twin Med LLC | 3d385a07-2a12-fce7-e063-6294a90a32d6 | 2025-12-01 | Warnings | M016 |
| ESTRIOL | ESTRIOL | Shenzhen Mengyue Technology Co., Ltd. | 44de9eb4-080e-bfbc-e063-6394a90ac0ea | 2025-12-01 | Warnings | M016 |
| CareALL Creamy Petroleum Jelly | PETROLATUM | New World Imports, Inc | e13fea4e-bd6d-425a-aa7e-1d41dc36bf00 | 2025-12-01 | Warnings | M016 |
| CareALL Creamy Cocoa Butter Petroleum Jelly | PETROLATUM | New World Imports, Inc | 9358b8ef-df14-45fc-9bfd-9052577a1f88 | 2025-12-01 | Warnings | M016 |
| CAREALL Zinc Oxide | ZINC OXIDE | New World Imports Inc | aa9ae4d1-4229-4894-9eaf-8588b2867472 | 2025-12-01 | Warnings | M016 |
| CAREALL Petroleum | PETROLATUM | New World Imports, Inc | 47e999de-08bd-4121-b6d0-270cc603b56d | 2025-12-01 | Warnings | M016 |
| HOEGOA Growth Hair Serum | GLYCERIN | Shantou Oralhoe Biotechnology Co., Ltd. | 44b6609f-c58b-b6ac-e063-6394a90a749b | 2025-11-29 | Warnings | M016 |
| OUHOE Micro Darts Tag gone Patch | GLYCERIN | Shantou Ouhoe Technology Co., Ltd. | 33ce447c-facd-35fb-e063-6394a90a1ead | 2025-11-27 | Warnings | M016 |
| OUHOE Herbal Hair Oil | GLYCERIN | Shantou Ouhoe Technology Co., Ltd. | 30c3df30-e0c6-4efa-e063-6294a90ac40a | 2025-11-27 | Warnings | M016 |
| OUHOE Aloe Soothing Sun Cream | GLYCERIN | Shantou Ouhoe Technology Co., Ltd. | 326781e0-55dc-80fc-e063-6394a90a09aa | 2025-11-27 | Warnings | M016 |
| OUHOE Ultra Anti-Acne Control Gel | GLYCERIN | Shantou Ouhoe Technology Co., Ltd. | 3bd1b734-76b0-5264-e063-6294a90a32d0 | 2025-11-27 | Warnings | M016 |
| OUHOE Lipoma Cream | GLYCERIN | Shantou Ouhoe Technology Co., Ltd. | 3cb4aed1-3b13-a62a-e063-6294a90a6c39 | 2025-11-27 | Warnings | M016 |
| OUHOE Para Crescimento | GLYCERIN | Shantou Ouhoe Technology Co., Ltd. | 42fbfcac-29ab-51f7-e063-6394a90a626f | 2025-11-27 | Warnings | M016 |
| OUHOE Biotin With Hydrolyzed Collagen | GLYCERIN | Shantou Ouhoe Technology Co., Ltd. | 43138915-5fe1-6e32-e063-6294a90abefa | 2025-11-27 | Warnings | M016 |
| EELHOE Pain Relief Patch | GLYCERIN | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 3f835843-eb04-6273-e063-6294a90ab2f0 | 2025-11-27 | Warnings | M016 |
| EELHOE Skin Tag Remover | GLYCERIN | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 32922508-74ae-8347-e063-6294a90a6154 | 2025-11-27 | Warnings | M016 |
| EELHOE Bodyacne Removal Cleanser | GLYCERIN | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 3bbebf1d-2e22-1427-e063-6294a90a7999 | 2025-11-27 | Warnings | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 617954 | calamine 8 % / zinc oxide 8 % Topical Lotion | PSN | fbcfa541-beda-06de-e053-6294a90a9298 | 3 |
| 617954 | calamine 80 MG/ML / zinc oxide 80 MG/ML Topical Lotion | SCD | fbcfa541-beda-06de-e053-6294a90a9298 | 3 |
| 617954 | calamine 8 % / zinc oxide 8 % Topical Lotion | SY | fbcfa541-beda-06de-e053-6294a90a9298 | 3 |
| 617954 | Calamine 80 MG/ML / ZNO 80 MG/ML Topical Lotion | SY | fbcfa541-beda-06de-e053-6294a90a9298 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 82645-418-96 | 82645041896 | 177 mL in 1 BOTTLE, PLASTIC (82645-418-96) | 177 ml | 2023-05-16 | No | No | Current |