REMEDY Calazime Skin Protectant
- Product NDC
- 53329-165
- 11-digit product format
- 533290165
- Labeler code
- 53329
- Product ID
- 53329-165_42658b90-1277-f5db-e063-6294a90a2460
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- calamine, menthol, white petrolatum, zinc oxide
- Dosage form
- PASTE
- Route
- TOPICAL
- Labeler
- Medline Industries, LP
- Application
- M015
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2012-03-23
- Marketing end
- 2027-07-01
- Substance
- FERRIC OXIDE RED; MENTHOL; ZINC OXIDE; PETROLATUM
- Active strength
- .5; .2; 19.5; 69 g/100g; g/100g; g/100g; g/100g
- NDC exclude flag
- No
- 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 | 2026-10-12 |
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 | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | 53329-165-96 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 53329-165-96 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 53329-165-96 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 53329-165-96 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 53329-165-96 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 53329-165-96 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 53329-165-96 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 53329-165-44 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 53329-165-96 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 53329-165-44 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 53329-165-96 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 53329-165-96 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 53329-165-44 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 53329-165-96 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 53329-165-44 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 53329-165-96 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 53329-165-44 | 557ba5c1ecfa… | 9c80585c8c6e… |
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
- REMEDY Calazime Skin Protectant
Active Ingredients#
| Ingredient | Strength |
|---|---|
| FERRIC OXIDE RED | .5 g/100g |
| MENTHOL | .2 g/100g |
| ZINC OXIDE | 19.5 g/100g |
| PETROLATUM | 69 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 |
| 53329-165-02 | 2023-08-08 | 165 REMEDY Calazime Skin Protectant |
| 53329-165-44 | 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 |
| 53329-165-96 | 2023-08-08 | 165 REMEDY Calazime Skin Protectant |
| 53329-165-02 | 2023-07-28 | 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 |
| 53329-165-44 | 2023-07-28 | 165 REMEDY Calazime Skin Protectant |
| 53329-165-96 | 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 |
|---|---|---|---|---|---|---|
| Pranicura 5 | GLYCERIN, KAOLIN, CALAMINE, MENTHOL | Pranicura Products LLC | af520a58-3f3c-4d28-a41f-3ed8f74da095 | 2025-11-04 | Warnings | M015 |
| ProCure ClamaPlex | ZINC OXIDE 20.625, MENTHOL 0.44, WHITE PETROLATUM 66.335 | Twin Med LLC | 3d366857-5178-9032-e063-6294a90a40f3 | 2025-11-01 | Warnings | M015 |
| GNP Hemorrhoidal | MINERAL OIL, PETROLATUM, PHENYLEPHRINE, HCL | Amerisource Bergen | b0f0ef97-9add-717f-e053-2a95a90a0eb0 | 2025-10-30 | Warnings | M015 |
| REMEDY Calazime Skin Protectant | CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE | Medline Industries, LP | 1295cfcc-5b61-481b-964b-f53ffd0cb58e | 2025-10-30 | Warnings | M015 53329-165 |
| Hemorrhoid Anesthetic | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL | Universal Distribution Center LLC | 186c2d32-e8c5-d13d-e063-6294a90a2b0e | 2025-10-30 | Warnings | M015 |
| Workvie | LIDOCAINE HCL, MENTHOL | Marketites LLC | aebaffb5-58dd-ebd5-e053-2a95a90a14ed | 2025-10-29 | Warnings | M015 |
| hemorrhoidal | GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM | Publix Super Markets Inc | 354a640c-bc7e-45c8-9df0-8b5b01767f5c | 2025-10-29 | Warnings | M015 |
| Hemorrhoidal | COCOA BUTTER, PHENYLEPHRINE HCL | Pharmacy Value Alliance LLC | 903b77fc-02bf-73b6-e053-2a95a90ad4cc | 2025-10-24 | Warnings | M015 |
| Hemorrhoidal | COCOA BUTTER, PHENYLEPHRINE HCL | CVS Pharmacy | 845fc11b-707d-2027-e053-2991aa0a1c8a | 2025-10-24 | Warnings | M015 |
| Calmol 4 | ZINC OXIDE AND COCOA BUTTER | Resical Inc. | 5516f800-d3fa-4b90-a3eb-c0bdf3183b9b | 2025-10-24 | Warnings | M015 |
| Hemorrhoidal | COCOA BUTTER, PHENYLEPHRINE HCL | Amerisourcebergen Drug Corporation | 231a850a-bad6-9a30-e063-6394a90a0fdc | 2025-10-24 | Warnings | M015 |
| Signature Care Hemorrhoidal Cream (with applicator) | PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, GLYCERIN, PETROLATUM | BETTER LIVING BRANDS, LLC | b026a386-5e38-52ed-e053-2a95a90a6b0e | 2025-10-24 | Warnings | M015 |
| Americaine | BENZOCAINE | Insight Pharmaceuticals LLC | d13c022f-2f91-40b4-bd66-0cfc0e147a5f | 2025-10-23 | Warnings | M015 |
| Winco Hemorrhoidal | MINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDE | Winco Foods, LLC | 04ca3ef1-fc6b-4683-b236-a75afc031fb5 | 2025-10-23 | Warnings | M015 |
| Signature Care Medicated Cooling | WITCH HAZEL | Better Living Brands, LLC | b35dc719-a5a2-4839-870d-25313d3f7c9b | 2025-10-22 | Warnings | M015 |
| Family Care Hemorrhoidal | MINERAL OIL | United Exchange Corp | 04375257-f4f3-48c3-a338-de43298b95eb | 2025-10-22 | Warnings | M015 |
| Family Wellness Hemorrhoidal | MINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HCL | Family Dollar Services, Inc | fe3293bc-80b5-b60a-e053-6394a90a4ede | 2025-10-22 | Warnings | M015 |
| Xesso Rear Comfort Glide | LIDOCAINE | PREMIUM NATURAL COSMETICS INC | e9eb262e-a1c1-7d5c-e053-2a95a90a7c9f | 2025-10-22 | Warnings | M015 |
| Adellina Lidocaine Numbing Cream Anorectal(Hemorrhoidal) Cream | LIDOCAINE | Guangzhou Haishi Biological Technology Co., Ltd. | 41a6d309-2722-1738-e063-6294a90a8a70 | 2025-10-21 | Warnings | M015 |
| DERMOSCRIBE ICHYBUM | HYDROCORTISONE, CLIOQUINOL, ZINC OXIDE | DERMOSCRIBE PTY LTD | 134a88a1-13e5-4da0-8270-c380b57aaeb7 | 2025-10-17 | Warnings | M015 |
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 |
|---|---|---|---|---|---|---|---|---|
| 53329-165-02 | 53329016502 | 3 TUBE in 1 BAG (53329-165-02) / 113 g in 1 TUBE (53329-165-44) | 3 tube | 2021-07-01 | 2027-07-01 | No | No | Current |
| 53329-165-44 | 53329016544 | 113 g in 1 TUBE (53329-165-44) | 113 g | 2018-03-14 | 2027-07-01 | No | No | Current |
| 53329-165-96 | 53329016596 | 144 PACKET in 1 BOX (53329-165-96) > 4 g in 1 PACKET | 144 packet | 2018-03-14 | 0000-00-00 | No | No | Current |