Humco Calamine
- Product NDC
- 0395-0413
- 11-digit product format
- 003950413
- Labeler code
- 0395
- Product ID
- 0395-0413_52b9f60d-7ae7-26c8-e063-6294a90acc20
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Calamine 8% and Zinc Oxide 8%
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Humco holding Group, Inc.
- 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
- 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
- Humco Calamine
- Listing expiration
- 2027-12-31
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 |
|---|---|
| f7dcd959-fb98-43bb-8dd3-a662bf8a053c | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0395-0413-96 | Humco Calamine | 177 mL in 1 BOTTLE, PLASTIC | LOTION | 177 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0395-0413-96 | ML - Milliliter | 0395-0413 | 7388d9e7-558f-47b8-9386-b0372be86ab3 | 1 | 2014-04-03 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Zinc Oxide | ACTIVE INGREDIENT | SOI2LOH54Z | HUMCO CALAMINE (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [HUMCO HOLDING GROUP, INC.] | 1 | |
| ZINC CATION | ACTIVE MOIETY | 13S1S8SF37 | HUMCO CALAMINE (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [HUMCO HOLDING GROUP, INC.] | 1 | |
| CALCIUM HYDROXIDE | INACTIVE INGREDIENT | PF5DZW74VN | HUMCO CALAMINE (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [HUMCO HOLDING GROUP, INC.] | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | HUMCO CALAMINE (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [HUMCO HOLDING GROUP, INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | HUMCO CALAMINE (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [HUMCO HOLDING GROUP, INC.] | 1 |
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 |
|---|---|---|---|---|---|---|
| JAYSUING Hair Treatment Green Ginger | GLYCERIN | Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd. | 2e8e70de-a2e0-7a71-e063-6294a90a90b8 | 2025-11-27 | Warnings | M016 |
| JAYSUING Liquid Wart Flat | GLYCERIN | Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd. | 3b0c05d1-a00e-97df-e063-6394a90af3d0 | 2025-11-27 | Warnings | M016 |
| JAYSUING 7 Days Nail Fungus Treatment | GLYCERIN | Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd. | 2ef424cc-815a-b331-e063-6394a90aae70 | 2025-11-27 | Warnings | M016 |
| JAYSUING Pain Relief Knee Patches | GLYCERIN | Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd. | 358a3e81-abb5-0a65-e063-6294a90a3d69 | 2025-11-27 | Warnings | M016 |
| Sandra Plasencia PDRN Rejuvenating Serum | RH-OLIGOPEPTIDE-1 | Guangzhou Meijiao Medical Biotechnology Co., Ltd. | 449634c8-ff99-1387-e063-6294a90aef45 | 2025-11-27 | Warnings | M016 |
| GLUTATHIONE | KOJIC ACIDSKIN LIGHTENING | HANCHOYEANBIOTEC Co.,Ltd. | 2be274be-e6d0-d961-e063-6294a90a2190 | 2025-11-27 | Warnings | M016 |
| XIMONTH Bee Venom Joint Cream | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 33d18888-8d06-da13-e063-6294a90a743c | 2025-11-26 | Warnings | M016 |
| XIMONTH Bee Venom Wart Remover Patch | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 3e6965b6-8f08-db62-e063-6394a90a64c9 | 2025-11-26 | Warnings | M016 |
| XIMONTH GLP-1 Patches | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 3d03cdfd-2e9e-f9a1-e063-6394a90a6a8b | 2025-11-26 | Warnings | M016 |
| XIMONTH Bee Venom Repair | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 37e40cc1-1121-1eee-e063-6294a90aab26 | 2025-11-26 | Warnings | M016 |
| XIMONTH Liquid Wart Corn Callus Remover | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 3a1b872a-2883-0b70-e063-6294a90af9d6 | 2025-11-26 | Warnings | M016 |
| XIMONTH Jimerito Honey For Eyes | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 3aa38704-4d2b-ffaf-e063-6294a90a323e | 2025-11-26 | Warnings | M016 |
| XIMONTH Bee Honey Eye Drops | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 3e69c950-bbbc-5c47-e063-6294a90a070e | 2025-11-26 | Warnings | M016 |
| Boudreauxs | ZINC OXIDE | C.B. Fleet Company, Inc. | 4c7e832e-55f3-4766-98b7-29b17d741a4b | 2025-11-26 | Warnings | M016 |
| Johnsons Baby Care Essentials Gift Set | ZINC OXIDE | Kenvue Brands LLC | 43edc287-57e1-d96e-e063-6294a90ac5a1 | 2025-11-24 | Warnings | M016 |
| Cetaphil Soothing Gel Cream | ALLANTOIN | Galderma Laboratories, L.P. | bab404f0-2f7a-4bac-b053-cbdc81c029b5 | 2025-11-24 | Warnings | M016 |
| health beyond VITAMINS AD | PETROLATUM | Nantong Health & Beyond Hygienic Products Inc. | de87da51-cf92-402c-b60f-5f28d1724124 | 2025-11-23 | Warnings | M016 |
| Medline | WHITE PETROLATUM | Medline Industries, LP | 00766a7b-797e-dd15-e063-6394a90af9ac | 2025-11-20 | Warnings | M016 |
| Itch Eraser Sensitive | SODIUM BICARBONATE | Tender Corporation d/b/a Adventure Ready Brands | 2250525a-45c2-42ea-e063-6394a90ac001 | 2025-11-18 | Warnings | M016 |
| Moisture Barrier Cream | PETROLATUM, ZINC OXIDE | Derma Sciences Canada Inc. | 43e01e22-7872-8e24-e063-6394a90a17ef | 2025-11-18 | Warnings | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 617954 | calamine 8 % / zinc oxide 8 % Topical Lotion | PSN | f7dcd959-fb98-43bb-8dd3-a662bf8a053c | 8 |
| 617954 | calamine 80 MG/ML / zinc oxide 80 MG/ML Topical Lotion | SCD | f7dcd959-fb98-43bb-8dd3-a662bf8a053c | 8 |
| 617954 | calamine 8 % / zinc oxide 8 % Topical Lotion | SY | f7dcd959-fb98-43bb-8dd3-a662bf8a053c | 8 |
| 617954 | Calamine 80 MG/ML / ZNO 80 MG/ML Topical Lotion | SY | f7dcd959-fb98-43bb-8dd3-a662bf8a053c | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0395-0413-96 | 00395041396 | 177 mL in 1 BOTTLE, PLASTIC (0395-0413-96) | 177 ml | 2017-11-13 | 0000-00-00 | No | No | Current |