Calamine
- Product NDC
- 68071-4322
- 11-digit product format
- 680714322
- Labeler code
- 68071
- Product ID
- 68071-4322_1a3dc619-6b13-21b4-e063-6294a90acb1e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- FERRIC OXIDE RED
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2013-01-07
- Substance
- FERRIC OXIDE RED; ZINC OXIDE
- Active strength
- 8; 8 g/mL; mg/mL
- 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 |
|---|---|
| FERRIC OXIDE RED | 8 g/mL |
| ZINC OXIDE | 8 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 |
|---|---|
| 66e98554-e158-a519-e053-2a91aa0a6783 | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2023-07-03 | Drug Facts |
| 2023-01-30 | Drug Facts |
| 2021-03-02 | Drug Facts |
| 2021-01-29 | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68071-4322-6 | Calamine | 177 mL in 1 BOTTLE | LOTION | 177 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68071-4322 | CALAMINE (FERRIC OXIDE RED) LOTION [NUCARE PHARMACEUTICALS,INC.] | 5 | Current NDC, Legacy NDC, 1 package rows | 20240706_66e98554-e158-a519-e053-2a91aa0a6783.zip |
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 |
|---|---|---|---|---|---|---|
| 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 |
| Petroleum Jelly | PETROLATUM | Walgreens | 1bb250ee-c4b7-4e9f-9d13-46ef9df4a9f5 | 2026-08-04 | Warnings | M016 |
| Nail Renewal Liquid | GLYCERIN | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 581f7192-fc17-a706-e063-6394a90a3ffa | 2026-08-03 | 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 |
| ATTITUDE Baby Leaves Diaper cream - Unscented | ZINC OXIDE | 9055-7588 Quebec Inc. (Attitude) | 579aa481-f8ec-b263-e063-6394a90a7754 | 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 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 617954 | calamine 8 % / zinc oxide 8 % Topical Lotion | PSN | 66e98554-e158-a519-e053-2a91aa0a6783 | 5 |
| 617954 | calamine 80 MG/ML / zinc oxide 80 MG/ML Topical Lotion | SCD | 66e98554-e158-a519-e053-2a91aa0a6783 | 5 |
| 617954 | calamine 8 % / zinc oxide 8 % Topical Lotion | SY | 66e98554-e158-a519-e053-2a91aa0a6783 | 5 |
| 617954 | Calamine 80 MG/ML / ZNO 80 MG/ML Topical Lotion | SY | 66e98554-e158-a519-e053-2a91aa0a6783 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68071-4322-6 | 68071432206 | 177 mL in 1 BOTTLE (68071-4322-6) | 177 ml | 2018-03-08 | 0000-00-00 | No | No | Current |