calamine
- Product NDC
- 0363-9410
- 11-digit product format
- 003639410
- Labeler code
- 0363
- Product ID
- 0363-9410_29f99f0a-e520-6d9d-e063-6394a90afb57
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Calamine and Zinc oxide
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- WALGREEN COMPANY
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-10-16
- 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 |
|---|---|
| fed3026b-3473-26fe-e053-6294a90a8aa2 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0363-9410-97 | calamine | 177 mL in 1 BOTTLE | 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 |
|---|---|---|---|---|---|---|
| TENA Proskin protective cream | ZINC OXIDE | Essity HMS North America Inc. | b840377f-a297-4aff-900e-7ea8b7c98717 | 2026-08-13 | Warnings, Adverse reactions | M016 |
| Medline | WHITE PETROLATUM, ZINC OXIDE | Medline Industries, LP | 087d66ff-1a8c-dcb2-e063-6294a90a2f8c | 2026-08-11 | Warnings | M016 |
| Nail Renewal Liquid | GLYCERIN | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 581f7192-fc17-a706-e063-6394a90a3ffa | 2026-08-11 | Warnings | M016 |
| Intertrigo Relief Cream | GLYCERIN | Shantou South Moon Biotechnology Co., Ltd. | 587220c9-0ae9-3438-e063-6394a90a0a86 | 2026-08-07 | Warnings | M016 |
| Calamine | FERRIC OXIDE RED | The Kroger Co. | 9ddcd6ba-1aed-48f8-a91a-54bd6f0d9308 | 2026-08-06 | Warnings, Adverse reactions | M016 |
| Petroleum Jelly, Lil Drug Store | PETROLATUM JELLY | Lil' Drug Store Products, Inc. | 5862af40-97e2-d792-e063-6394a90a0f1a | 2026-08-06 | Warnings | M016 |
| AOAO RAPID ACNE RELIEF | SALICYLIC ACID,BENZOYL PEROXIDE | Guangzhou Senmai Biotechnology Co.,Ltd. | 586df874-0f71-ed46-e063-6294a90a0a8e | 2026-08-06 | Warnings | M016 |
| Dealmed Vitamins A and D | WHITE PETROLATUM | Dealmed Medical Supplies, LLC. | d6584809-b438-4b2c-ab37-522e0dbef470 | 2026-08-05 | Warnings | M016 |
| Dealmed Vitamins A and D | PETROLATUM | Dealmed Medical Supplies, LLC. | 84afe4ae-f9e8-406f-9fbe-f413975f86eb | 2026-08-05 | Warnings | M016 |
| Petroleum Jelly | PETROLATUM | Walgreens | 1bb250ee-c4b7-4e9f-9d13-46ef9df4a9f5 | 2026-08-04 | Warnings | M016 |
| Nail Treatment Repairing Liquid | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 57b8b3e5-88be-3a91-e063-6294a90a05be | 2026-08-03 | Warnings | M016 |
| PROCURE | ZINC OXIDE | TWIN MED, LLC | e68ae97e-668e-31c2-e053-2995a90ab4d3 | 2026-08-03 | Warnings | M016 |
| PROCURE VITAMIN A AND D Skin Protectant | PETROLATUM | TWIN MED, LLC | bbbca68e-1b65-49b1-a5fa-ed4da55d05e3 | 2026-08-03 | Warnings | M016 |
| procure | PETROLATUM | TWIN MED, LLC | 32520d8f-91ee-47a1-9129-bf0746791f4b | 2026-08-03 | Warnings | M016 |
| ProCure HydroShield | PETROLATUM 44.28% | Twin Med LLC | 3ab7bfb2-bbcf-0822-e063-6294a90af084 | 2026-08-03 | Warnings | M016 |
| 456 Acne Relief Cream | NIACINAMIDE,SALICYLIC ACID,CENTELLA ASIATICA ROOT,COPTIS CHINENSIS ROOT | Guangzhou Senmai Biotechnology Co.,Ltd. | 5830fd36-0613-1980-e063-6294a90adfb7 | 2026-08-03 | Warnings | M016 |
| Crogooe Skin Relief Cream | COLLOIDAL OATMEAL | Guangdong Outeli Biotechnology Co., Ltd. | 57f9b3e8-25d3-2b20-e063-6394a90aaea5 | 2026-08-01 | Warnings | M016 |
| First Aid Beauty Sensitive Skin Bestsellers Kit | COLLOIDAL OATMEAL | JCS Global Distribution, Inc. | 57c3556a-aad3-3e65-e063-6394a90ab689 | 2026-07-29 | 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 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 617954 | calamine 8 % / zinc oxide 8 % Topical Lotion | PSN | fed3026b-3473-26fe-e053-6294a90a8aa2 | 3 |
| 617954 | calamine 80 MG/ML / zinc oxide 80 MG/ML Topical Lotion | SCD | fed3026b-3473-26fe-e053-6294a90a8aa2 | 3 |
| 617954 | calamine 8 % / zinc oxide 8 % Topical Lotion | SY | fed3026b-3473-26fe-e053-6294a90a8aa2 | 3 |
| 617954 | Calamine 80 MG/ML / ZNO 80 MG/ML Topical Lotion | SY | fed3026b-3473-26fe-e053-6294a90a8aa2 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0363-9410-97 | 00363941097 | 177 mL in 1 BOTTLE (0363-9410-97) | 177 ml | 2023-10-16 | No | No | Current |