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 |
|---|---|---|---|---|---|---|
| Signature Numb cream | 5% LIDOCAINE | Shengnan (Guangzhou) Cosmetics Co., LTD | 3d2ecb86-6bb1-2528-e063-6394a90a8d89 | 2025-08-25 | Warnings | M015 |
| Cooling Perineal Pad Liners | COOLING PERINEAL | ELEEO BRANDS LLC | 29a433bc-a833-ffc7-e063-6294a90a465a | 2025-08-25 | Warnings | M015 |
| Signature numbing cream | 5% LIDOCAINE | Shengnan (Guangzhou) Cosmetics Co., LTD | 3d3b771f-5e30-b23e-e063-6294a90a3fb2 | 2025-08-25 | Warnings | M015 |
| Exchange Select Hemorrhoidal | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL | Army & Air Force Exchange Service | 6c32af3e-5b60-4e3e-95c2-ada37a7d3b2a | 2025-08-22 | Warnings | M015 |
| Hemorrhoidal | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL | Padagis Israel Pharmaceuticals Ltd | 43826c68-0a20-460d-a7b5-f3e12395a7d0 | 2025-08-22 | Warnings | M015 |
| Barrier Protectant Cream | BARRIER CREAM | Cardinal Health | 539d9aac-75cf-4efd-bb3e-b465563304ca | 2025-08-21 | Warnings | M015 |
| Lidocaine Patch | LIDOCAINE 4% | SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS | 0a31ba9a-8283-4bf8-b6c6-6e331465622f | 2025-08-20 | Warnings | M015 |
| VBBV Anorectal(Hemorrhoidal) Creams | LIDOCAINE | Jiashen International Trading Co., Ltd. | 3cba84ea-5ee0-7ee3-e063-6294a90af11b | 2025-08-19 | Warnings | M015 |
| Hemorrhoidal | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL | Publix Super Markets Inc | 7b360d3b-fb2b-4f35-a04d-203dd352933d | 2025-08-19 | Warnings | M015 |
| Good Sense Hemorrhoidal | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL | L. Perrigo Company | 2492ee1b-01f1-46e7-8790-b6ebc48f2aff | 2025-08-19 | Warnings | M015 |
| Norms Hemorrhoid | PHENYLEPHRINE HYDROCHLORIDE, WITCH HAZEL | Totally Normal Company | 3c98cc12-2476-9f73-e063-6394a90a6f23 | 2025-08-17 | Warnings | M015 |
| Upside Down Pain Relief | BENZOCAINE, GLYCERIN | Fridababy, LLC | 31c2cd25-1fec-5ec5-e063-6394a90a24b4 | 2025-08-15 | Warnings | M015 |
| DG Health Hemorrhoidal | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL | Dolgencorp, LLC | d9f12a34-7bd1-4ba5-b34b-1b641f58271a | 2025-08-12 | Warnings | M015 |
| Norms Hemorrhoid | GLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCL | Totally Normal Company | 3bdf8c74-3db6-1805-e063-6394a90aaba0 | 2025-08-08 | Warnings | M015 |
| Asteroid | MENTHOL, PETROLATUM, ZINC OXIDE | HEALTHTEX LIMITED | 29d1e46d-0189-4f9e-9963-8a9de2757f28 | 2025-07-30 | Warnings | M015 |
| Comfort Candy Hemorrhoidal | LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE | BOWLER ESTHETICS, INC | 4951d984-3e86-4eb6-9505-2c506e22fda2 | 2025-07-23 | Warnings | M015 |
| Doctor Butler Hemorrhoid and Fissure Advanced Formula | GLYCERIN 37.5%, LANOLIN 12.5%, LIDOCAINE 4%, ZINC OXIDE 5% | Beyond Health, PA | d2a769e2-afd0-aed2-e053-2995a90ad429 | 2025-07-23 | Warnings | M015 |
| Dr Butlers Hemorrhoid | WITCH HAZEL 50% | Beyond Health, PA | 3a9fea0c-b189-c77e-e063-6294a90a0583 | 2025-07-23 | Warnings | M015 |
| Dr Butlers Advanced Hemorrhoid Relief | LIDOCAINE HCL 5%, PHENYLEPHRINE HCL 0.25%, WITCH HAZEL 50% | Beyond Health. PA | 3aa0ee7a-3863-254d-e063-6394a90ad40e | 2025-07-23 | Warnings | M015 |
| Dr. Butler Hemorrhoid Treatment | PHENYLEPHRINE HYDROCHLORIDE 0.25%, WITCH HAZEL 50% | Beyond Health P.A. | d2d1c81c-6443-c4b7-e053-2995a90a14d7 | 2025-07-22 | 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 |