REMEDY Calazime Skin Protectant
- Product NDC
- 53329-165
- Requested package NDC
- 53329-165-96
- 11-digit product format
- 533290165
- Labeler code
- 53329
- Product ID
- 53329-165_2cdaa63c-2a2f-2fde-e063-6394a90a70c6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- calamine, menthol, white petrolatum, zinc oxide
- Dosage form
- PASTE
- Route
- TOPICAL
- Labeler
- Medline Industries, LP
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2012-03-23
- Substance
- FERRIC OXIDE RED; MENTHOL; PETROLATUM; ZINC OXIDE
- Active strength
- .5; .2; 69; 19.5 g/100g; g/100g; g/100g; g/100g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 53329-165 | 53329-165-96 | D | Discontinued by firm | 2026-08-07 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- REMEDY Calazime Skin Protectant
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| FERRIC OXIDE RED | .5 g/100g |
| MENTHOL | .2 g/100g |
| ZINC OXIDE | 69 g/100g |
| PETROLATUM | 19.5 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1K09F3G675 | Internal UNII lookup |
| L7T10EIP3A | Internal UNII lookup |
| SOI2LOH54Z | Internal UNII lookup |
| 4T6H12BN9U | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1921772 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1295cfcc-5b61-481b-964b-f53ffd0cb58e | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 7b19f89e-0a13-4d4e-a994-a46d39d008b9 | Product name | 1 | 20251120 |
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| 13c3e0af-2da2-8aec-9e17-1afd680d80c2 | Product name | 8 | 20221116 |
| c5cd4727-ac49-4409-82b1-5bd8006c3ec7 | Product name | 1 | 20171122 |
| 5e18e798-5614-cf5c-0185-38b1cb77a093 | Product name | 2 | 20160822 |
| f46c867f-cde5-4f14-a7c1-18ae3a6efd1c | Product name | 1 | 20160303 |
| ebc62596-fc97-4d03-9483-7ba095d25db7 | Product name | 1 | 20151210 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| 60c52429-fcef-eb54-2387-43bc9e4f296b | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 53329-165-02 | 2023-08-08 | 165 REMEDY Calazime Skin Protectant |
| 53329-165-44 | 2023-08-08 | 165 REMEDY Calazime Skin Protectant |
| 53329-165-96 | 2023-08-08 | 165 REMEDY Calazime Skin Protectant |
| 53329-165-02 | 2023-07-28 | 165 REMEDY Calazime Skin Protectant |
| 53329-165-44 | 2023-07-28 | 165 REMEDY Calazime Skin Protectant |
| 53329-165-96 | 2023-07-28 | 165 REMEDY Calazime Skin Protectant |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53329-165-02 | REMEDY Calazime Skin Protectant | 3 in 1 BAG | PASTE | 3 | 9 | |
| 53329-165-44 | REMEDY Calazime Skin Protectant | 113 g in 1 TUBE | PASTE | 113 | 9 | |
| 53329-165-96 | REMEDY Calazime Skin Protectant | 4 g in 1 PACKET | PASTE | 4 | 9 | |
| 53329-165-96 | REMEDY Calazime Skin Protectant | 144 in 1 BOX | PASTE | 144 | 9 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 53329-165-44 | GM - Gram | 53329-165 | a485e81b-8b21-4e4e-83f9-8ba27da044a4 | 1 | 2013-07-02 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53329-165 | REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, LP] | 9 | Current NDC, Legacy NDC, 4 package rows | 20250130_1295cfcc-5b61-481b-964b-f53ffd0cb58e.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 |
|---|---|---|---|---|---|---|
| Nail Fungus Repairing Liquid | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 57b8b3e5-88be-3a91-e063-6294a90a05be | 2026-07-28 | 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 |
| 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 |
| Estriol Cream | ESTRIOL | Guangxi Keyun E-commerce Co., Ltd. | 4deadcb6-0d46-bdd7-e063-6294a90a26d7 | 2026-07-23 | Warnings | M016 |
| DERMFREE Vein Target Microneedle Patch | ALLANTOIN 1% VEIN TARGET MICRONEEDLE PATCH | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 57449e29-ec46-9c30-e063-6394a90a7b4a | 2026-07-23 | Warnings | M016 |
| Baby Vitamin A and D | LANOLIN 15.5%, PETROLATUM 53.4% | Walgreen Company | 25a125ea-6f9f-310c-e063-6394a90acef2 | 2026-07-22 | Warnings | M016 |
| First Aid A and D | LANOLIN 15.5%, PETROLATUM 53.4% | Walgreen Company | 25a319d0-d39a-5ff0-e063-6394a90a671d | 2026-07-22 | Warnings | M016 |
| Calamine | CALAMINE AND ZINC OXIDE | Marie's Original Formulas LLC | 57110309-9a3d-025f-e063-6394a90a015a | 2026-07-22 | Warnings | M016 |
| Dermasporin | LANOLIN | Marie's Original Formulas LLC | 562f40aa-eeec-2b7c-e063-6294a90ad68d | 2026-07-22 | Warnings | M016 |
| CAREALL Vitamin A and D | PETROLATUM | New World Imports, Inc | ef89a68a-74c1-4c42-8078-b7a208ace0de | 2026-07-22 | Warnings | M016 |
| Dermact | LANOLIN | Marie's Original Formulas LLC | 57121dbe-e886-a562-e063-6294a90a367f | 2026-07-22 | Warnings | M016 |
| Universal WITCH HAZEL | WITCH HAZEL | Universal Distribution Center LLC | 7e0b56ef-fa41-4862-b387-5b58d81d67d4 | 2026-07-22 | Warnings | M016 |
| Aveeno Soothing Bath Treatment | OATMEAL | Kenvue Brands LLC | 0c410b8e-025f-477c-afac-6e2e9ac88f7d | 2026-07-21 | Warnings | M016 |
| DERMFREE SCAR SHEETS | SILICONE GEL 1% SCAR SHEETS | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a4ce316-4b92-7e81-e063-6294a90af6db | 2026-07-21 | Warnings | M016 |
| DERMFREE VARICOSE VEINS | DIMETHICONE 3% VARICOSE VEINS | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a5a2d1d-9e84-18eb-e063-6394a90a97ee | 2026-07-21 | Warnings | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1921772 | calamine 3.5 % / menthol 0.2 % / petrolatum 69 % / zinc oxide 16.5 % Topical Paste | PSN | 1295cfcc-5b61-481b-964b-f53ffd0cb58e | 9 |
| 1921772 | calamine 0.035 MG/MG / menthol 0.002 MG/MG / petrolatum 0.69 MG/MG / zinc oxide 0.165 MG/MG Paste | SCD | 1295cfcc-5b61-481b-964b-f53ffd0cb58e | 9 |
| 1921772 | Calamine 0.035 MG/MG / Menthol 0.002 MG/MG / Petrolatum 0.69 MG/MG / ZNO 0.165 MG/MG Paste | SY | 1295cfcc-5b61-481b-964b-f53ffd0cb58e | 9 |
| 1921772 | calamine 3.5 % / menthol 0.2 % / petrolatum 69 % / zinc oxide 16.5 % Topical Paste | SY | 1295cfcc-5b61-481b-964b-f53ffd0cb58e | 9 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53329-165-96 | 53329016596 | 144 PACKET in 1 BOX (53329-165-96) > 4 g in 1 PACKET | 144 packet | 2018-03-14 | 2023-12-13 | No | No | Current |