Calamine
- Product NDC
- 41163-536
- 11-digit product format
- 411630536
- Labeler code
- 41163
- Product ID
- 41163-536_5aa99c82-3d5d-b0a0-e063-6394a90a1b11
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Calamine, Pramoxine HCl
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- United Natural Foods, Inc. dba UNFI
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2009-05-21
- Substance
- FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE
- Active strength
- 80; 10 mg/mL; mg/mL
- 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 |
| PRAMOXINE HYDROCHLORIDE | 10 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1K09F3G675 | Internal UNII lookup |
| 88AYB867L5 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1234532 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 7792dadb-52b6-46b6-8fdf-80b1171065b5 | Product name | 1 | 20180810 |
| 58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8 | Product name | 1 | 20140508 |
| 9869efd7-d6dd-0665-5b67-53adbe6ef15e | Product name | 1 | 20140508 |
| a7051cba-790b-a699-81f8-dbbbdbd9b5ac | Product name | 1 | 20140508 |
| da108d9e-edc8-17a3-8c28-3251c6a8accc | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 41163-536-30 | Calamine | 177 mL in 1 BOTTLE, PLASTIC | LOTION | 177 | 7 |
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 |
|---|---|---|---|---|---|---|
| VERADEX-E | PETROLATUM AND LANOLIN | ABBE Laboratories, Inc. | 00100102-c245-4b63-a4ff-794cacda6f17 | 2026-01-24 | Warnings | M016 |
| Hydrocortisone | DRS. HYDROCORTISONE | OL PHARMA TECH,LLC | b0eac8f3-bb80-6563-e053-2995a90a83c9 | 2026-01-22 | Warnings | M016 |
| Eczema Reliegf Skin Protectant EQB | COLLOIDAL OATMEAL 2% | Walmart | 37132a0d-37c5-4b21-9673-5f853b3a6248 | 2026-01-20 | Warnings | M016 |
| Skin Relief Cream | HYDROCORTISONE | Spa de Soleil | 0a90b77a-4be4-71c5-e063-6294a90a8e41 | 2026-01-20 | Warnings | M016 |
| Cold Sore Bandage | COLD SORE BANDAGE | Shenzhen Hengdasheng Technology Co., Ltd | 47f588a2-a69b-cffe-e063-6294a90a0ed4 | 2026-01-17 | Warnings | M016 |
| Nail Repairs Patches | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 48793a50-89a7-dba9-e063-6394a90a7056 | 2026-01-16 | Warnings | M016 |
| HAND SANITIZER | HAND SANITIZER | Guangdong bangze medicine co., ltd | 40018618-8f95-f6db-e063-6394a90ac7dd | 2026-01-16 | Warnings | M016 |
| Lemon Glycerin | GLYCERIN | Jianerkang Medical Co., Ltd | edee14da-13d8-4bc2-9c37-cfc353763d11 | 2026-01-16 | Warnings | M016 |
| WORKMANS FRIEND SUPERIOR BARRIER SKIN | DIMETHICONE | SolvChem, Inc. | da12ac2c-1af9-47b1-aa5f-77acb48535ba | 2026-01-16 | Warnings | M016 |
| Walgreens Vitamin A and D skin protectant | LANOLIN, PETROLATUM | Walgreen Company | 9aa6c7f2-0923-4d51-8b9b-63f9a724937a | 2026-01-15 | Warnings | M016 |
| INCONTINENCE CARE WIPE | DIMETHICONE | Cardinal Health 200, Inc. | 1ac34c94-9e3b-45f2-ba19-a07dcd3941dd | 2026-01-15 | Warnings | M016 |
| Alcohol Hand Sanitizer | ALCOHOL HAND SANITIZER | Guangdong bangze medicine co., ltd | 2e8b5afe-6ff8-3e9b-e063-6394a90ad703 | 2026-01-14 | Warnings | M016 |
| Alcohol Sanitizer | ALCOHOL SANITIZER SPRAY | Guangdong bangze medicine co., ltd | 2e9db49b-35ce-00d5-e063-6294a90acf35 | 2026-01-14 | Warnings | M016 |
| GG XEROZINE 15 | SKIN PROTECTANT | GERI-GENTLE CORPORATION | e6881c6d-f584-26d0-e053-2995a90a3873 | 2026-01-14 | Warnings | M016 |
| Medpura Zinc Oxide 20% | MEDPURA ZINC OXIDE 20% | Akron Pharma Inc. | 3a63aaea-087e-4115-8478-64d416e6085f | 2026-01-14 | Warnings | M016 |
| Walgreens Baby Petroleum | PETROLATUM | Walgreen Company | e79f2bc2-e53b-4d01-9f9b-d9bd5c3b230d | 2026-01-14 | Warnings | M016 |
| Walgreens Cocoa Butter Jelly | PETROLEUM | Walgreens | 32b84286-471a-4d15-80fb-2f516dc1d6ea | 2026-01-14 | Warnings | M016 |
| Hydrating Healing Skin Protectant | PETROLATUM OINTMENT | CVS Pharmacy | c129c2b0-10d5-4b5d-ac5c-2e2512e61279 | 2026-01-14 | Warnings | M016 |
| Multi-Purpose Skin Protectant | A AND D OINTMENT | CVS Pharmacy | 60bd0095-25d3-44af-9502-0c63b3d25e66 | 2026-01-14 | Warnings | M016 |
| Kenkoderm Eczema Honey Intensive Soothing Balm | KENKODERM ECZEMA HONEY INTENSIVE SOOTHING BALM | Guangzhou Ariel Biotech Co., Ltd. | 48652b9c-4063-cc16-e063-6394a90a3b86 | 2026-01-14 | Warnings | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1234532 | calamine 8 % / pramoxine HCl 1 % Topical Lotion | PSN | 0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea | 7 |
| 1234532 | calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion | SCD | 0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea | 7 |
| 1234532 | calamine 8 % / pramoxine hydrochloride 1 % Topical Lotion | SY | 0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 41163-536-30 | 41163053630 | 177 mL in 1 BOTTLE, PLASTIC (41163-536-30) | 177 ml | 2009-05-21 | 0000-00-00 | No | No | Current |