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 | 2026-10-15 |
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 |
|---|---|---|---|---|---|---|
| Medline | MENTHOL, WHITE PETROLATUM, ZINC OXIDE | Medline Industries, LP | 006539c9-1982-d6de-e063-6294a90a1a5a | 2025-10-17 | Warnings | M015 |
| Xesso Strawberry Rear Comfort Glide 4% Lidocaine | LIDOCAINE | Premium Natural Cosmetics Inc | efba09fc-6dd7-0f73-e053-2995a90a628a | 2025-10-17 | Warnings | M015 |
| medicated pads | WITCH HAZEL | TARGET CORPORATION | acd0d99d-2a77-4227-bebb-c819f4a52666 | 2025-10-14 | Warnings | M015 |
| Acolye Numbing Cream Anorectal(Hemorrhoidal) Cream | LIDOCAINE | Guangzhou Haishi Biological Technology Co., Ltd. | 40b0e8d6-4686-960b-e063-6294a90a016e | 2025-10-09 | Warnings | M015 |
| Acolye Numbing Cream Anorectal(Hemorrhoidal) Cream | LIDOCAINE | Guangzhou Haishi Biological Technology Co., Ltd. | 40b452a3-76b7-2433-e063-6294a90ab6b4 | 2025-10-09 | Warnings | M015 |
| EQUATE HEMORRHOID RELIEF | LIDOCAIN 5% | WALMART, INC | d96e8152-e36e-22fc-e053-2995a90a8b2b | 2025-10-08 | Warnings | M015 |
| Pramoxine Hydrochloride Anorectal | PRAMOXINE HYDROCHLORIDE | Stratus Pharmaceuticals | 39a16b66-b0e9-412f-8773-8dec0a1227e0 | 2025-10-02 | Warnings | M015 |
| Doctor Butlers Hemorrhoid and Fissure External Pain Formula | LIDOCAINE 5% | Beyond Health, P.A. | d92f22a7-c0b5-d8b8-e053-2a95a90a2376 | 2025-09-30 | Warnings | M015 |
| RWWXII Deep Numbing Cream(Anorectal Hemorrhoidal Cream) | LIDOCAINE | Guangzhou Haishi Biological Technology Co., Ltd. | 3ffc57c7-5bf4-cba8-e063-6394a90a322f | 2025-09-29 | Warnings | M015 |
| Hemorrhoidal Pain Relief | HEMORRHOIDAL PAIN RELIEF CREAM | Neilmed Pharmaceuticals Inc. | 374dc1c0-4243-b272-e063-6394a90a5a6b | 2025-09-24 | Warnings | M015 |
| Medi-First Burn | LIDOCAINE HYDROCHLORIDE | Unifirst First Aid Corporation | 44bb5f25-1114-4bb1-8bcf-40402594abc4 | 2025-09-09 | Warnings | M015 |
| Dr. Care Numbing Cream | 5% LIDOCAINE | Shengnan (Guangzhou) Cosmetics Co., LTD | 3e456af7-9726-d17e-e063-6394a90ab560 | 2025-09-08 | Warnings | M015 |
| Medi-first Ivy-Rid First Aid | BENZOCAINE AND BENZETHONIUM CHLORIDE | Unifirst First Aid Corporation | 905c97ad-0bba-46b1-939c-f16fbdb02818 | 2025-09-08 | Warnings | M015 |
| MediFirst Burn | LIDOCAINE HYDROCHLORIDE | Unifirst First Aid Corporation | 9fa5b348-29c2-4cd0-a945-0486bd27f5e0 | 2025-09-08 | Warnings | M015 |
| Medi-First Burn | LIDOCAINE HCL | Unifirst First Aid Corporation | b3ebf104-cc51-0ef5-e053-2a95a90a25c9 | 2025-09-08 | Warnings | M015 |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Unifirst First Aid Corporation | 4c2e2b91-d2f6-4e41-9a4c-ecabca9830e8 | 2025-09-08 | Warnings | M015 |
| Pain Relief | ANALGESIC MENTHOL | Unifirst First Aid Corporation | 8162d22d-04c0-de07-e053-2991aa0a9975 | 2025-09-08 | Warnings | M015 |
| Green Guard Burn | LIDOCAINE HCL | Unifirst First Aid Corporation | b451e96f-fcba-6495-e053-2a95a90a2adf | 2025-09-08 | Warnings | M015 |
| Lidochill(TM) Gel | LIDOCAINE HCL 4%, MENTHOL 1% | PureTek Corporation | d2a9aeb6-8a94-49e7-ab46-84403560b6c8 | 2025-09-08 | Warnings | M015 |
| Signature numbing cream | 5% LIDOCAINE | Shengnan (Guangzhou) Cosmetics Co., LTD | 3e1892de-378b-d2d0-e063-6294a90ad7db | 2025-09-05 | 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 |