FDA.reportPublic FDA data

Remedy Nutrashield

Product NDC
53329-157
11-digit product format
533290157
Labeler code
53329
Product ID
53329-157_423ded59-4687-2c7b-e063-6294a90a6797
Type
HUMAN OTC DRUG
Nonproprietary name
Dimethicone
Dosage form
LOTION
Route
TOPICAL
Labeler
Medline Industries, LP
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2005-06-01
Substance
DIMETHICONE
Active strength
1 g/100mL
Pharmacologic classes
Skin Barrier Activity [PE]
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.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage53329-15753329-157-13DDiscontinued by firm2026-10-12
excluded packagepackage53329-15753329-157-77DDiscontinued by firm2026-10-12
excluded packagepackage53329-15753329-157-96DDiscontinued by firm2026-10-12

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.

Historic NDC status page 1 of 1 · 39 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0553329-157-13d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0553329-157-77d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0553329-157-96d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2653329-157-96f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2653329-157-13f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2653329-157-77f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3153329-157-962ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3153329-157-132ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3153329-157-772ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2853329-157-96a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2853329-157-13a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2853329-157-77a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2153329-157-96cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2153329-157-13cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2153329-157-77cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1053329-157-96cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1053329-157-13cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1053329-157-77cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3153329-157-96302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3153329-157-13302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3153329-157-77302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2053329-157-96ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2053329-157-13ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2053329-157-77ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1053329-157-960efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1053329-157-130efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1053329-157-770efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0853329-157-04ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0853329-157-77ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0853329-157-13ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0853329-157-96ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0353329-157-04367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0353329-157-77367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0353329-157-13367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0353329-157-96367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0953329-157-04557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0953329-157-77557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0953329-157-13557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0953329-157-96557ba5c1ecfa…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 Nutrashield
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE1 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
92RU3N3Y1OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
199680Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ed8a08a7-594c-46e2-b70f-b75b2960141fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7b19f89e-0a13-4d4e-a994-a46d39d008b9Product name120251120
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
13c3e0af-2da2-8aec-9e17-1afd680d80c2Product name820221116
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
f46c867f-cde5-4f14-a7c1-18ae3a6efd1cProduct name120160303
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
53329-157-022023-08-08157 Remedy Olivamine Nutrashield
53329-157-022023-08-08157 Remedy Olivamine Nutrashield
53329-157-042023-08-08157 Remedy Olivamine Nutrashield
53329-157-042023-08-08157 Remedy Olivamine Nutrashield
53329-157-132023-08-08157 Remedy Olivamine Nutrashield
53329-157-132023-08-08157 Remedy Olivamine Nutrashield
53329-157-772023-08-08157 Remedy Olivamine Nutrashield
53329-157-772023-08-08157 Remedy Olivamine Nutrashield
53329-157-962023-08-08157 Remedy Olivamine Nutrashield
53329-157-962023-08-08157 Remedy Olivamine Nutrashield
53329-157-022023-07-28157 Remedy Olivamine Nutrashield
53329-157-022023-07-28157 Remedy Olivamine Nutrashield
53329-157-042023-07-28157 Remedy Olivamine Nutrashield
53329-157-042023-07-28157 Remedy Olivamine Nutrashield
53329-157-132023-07-28157 Remedy Olivamine Nutrashield
53329-157-132023-07-28157 Remedy Olivamine Nutrashield
53329-157-772023-07-28157 Remedy Olivamine Nutrashield
53329-157-772023-07-28157 Remedy Olivamine Nutrashield
53329-157-962023-07-28157 Remedy Olivamine Nutrashield
53329-157-962023-07-28157 Remedy Olivamine Nutrashield

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-157-02Remedy Nutrashield3 in 1 BAGLOTION313
53329-157-04Remedy Nutrashield118 mL in 1 TUBELOTION11813
53329-157-13Remedy Nutrashield59 mL in 1 TUBELOTION5913
53329-157-77Remedy Nutrashield4 mL in 1 PACKETLOTION413
53329-157-96Remedy Nutrashield4 mL in 1 PACKETLOTION413
53329-157-96Remedy Nutrashield144 in 1 BOXLOTION14413

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53329-157-04ML - Milliliter53329-1579794efa7-fc17-456a-adaf-abe857ed024212012-07-24
53329-157-13ML - Milliliter53329-1571d2f34d3-4fe3-4ecb-aeec-77594742c30d12012-07-24
53329-157-96ML - Milliliter53329-157f642d659-06e7-463b-bb4b-f80302f0970712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OREMEDY NUTRASHIELD (DIMETHICONE) LOTION [MEDLINE INDUSTRIES, INC.]2
DIMETHICONEACTIVE MOIETY92RU3N3Y1OREMEDY NUTRASHIELD (DIMETHICONE) LOTION [MEDLINE INDUSTRIES, INC.]2
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1REMEDY NUTRASHIELD (DIMETHICONE) LOTION [MEDLINE INDUSTRIES, INC.]2
ACETYLCYSTEINEINACTIVE INGREDIENTWYQ7N0BPYCREMEDY NUTRASHIELD (DIMETHICONE) LOTION [MEDLINE INDUSTRIES, INC.]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XREMEDY NUTRASHIELD (DIMETHICONE) LOTION [MEDLINE INDUSTRIES, INC.]2
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RREMEDY NUTRASHIELD (DIMETHICONE) LOTION [MEDLINE INDUSTRIES, INC.]2
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0NREMEDY NUTRASHIELD (DIMETHICONE) LOTION [MEDLINE INDUSTRIES, INC.]2
CHOLECALCIFEROLINACTIVE INGREDIENT1C6V77QF41REMEDY NUTRASHIELD (DIMETHICONE) LOTION [MEDLINE INDUSTRIES, INC.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPREMEDY NUTRASHIELD (DIMETHICONE) LOTION [MEDLINE INDUSTRIES, INC.]2
CORN OILINACTIVE INGREDIENT8470G57WFMREMEDY NUTRASHIELD (DIMETHICONE) LOTION [MEDLINE INDUSTRIES, INC.]2
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RREMEDY NUTRASHIELD (DIMETHICONE) LOTION [MEDLINE INDUSTRIES, INC.]2
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4REMEDY NUTRASHIELD (DIMETHICONE) LOTION [MEDLINE INDUSTRIES, INC.]2
DIMETHYL SULFONEINACTIVE INGREDIENT9H4PO4Z4FTREMEDY NUTRASHIELD (DIMETHICONE) LOTION [MEDLINE INDUSTRIES, INC.]2
GLYCINEINACTIVE INGREDIENTTE7660XO1CREMEDY NUTRASHIELD (DIMETHICONE) LOTION [MEDLINE INDUSTRIES, INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TREMEDY NUTRASHIELD (DIMETHICONE) LOTION [MEDLINE INDUSTRIES, INC.]2
NIACINAMIDEINACTIVE INGREDIENT25X51I8RD4REMEDY NUTRASHIELD (DIMETHICONE) LOTION [MEDLINE INDUSTRIES, INC.]2
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1EREMEDY NUTRASHIELD (DIMETHICONE) LOTION [MEDLINE INDUSTRIES, INC.]2
ORANGE OILINACTIVE INGREDIENTAKN3KSD11BREMEDY NUTRASHIELD (DIMETHICONE) LOTION [MEDLINE INDUSTRIES, INC.]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQREMEDY NUTRASHIELD (DIMETHICONE) LOTION [MEDLINE INDUSTRIES, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3REMEDY NUTRASHIELD (DIMETHICONE) LOTION [MEDLINE INDUSTRIES, INC.]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHREMEDY NUTRASHIELD (DIMETHICONE) LOTION [MEDLINE INDUSTRIES, INC.]2
PYRIDOXINE HYDROCHLORIDEINACTIVE INGREDIENT68Y4CF58BVREMEDY NUTRASHIELD (DIMETHICONE) LOTION [MEDLINE INDUSTRIES, INC.]2
SAFFLOWER OILINACTIVE INGREDIENT65UEH262ISREMEDY NUTRASHIELD (DIMETHICONE) LOTION [MEDLINE INDUSTRIES, INC.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XREMEDY NUTRASHIELD (DIMETHICONE) LOTION [MEDLINE INDUSTRIES, INC.]2
VANILLININACTIVE INGREDIENTCHI530446XREMEDY NUTRASHIELD (DIMETHICONE) LOTION [MEDLINE INDUSTRIES, INC.]2
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCREMEDY NUTRASHIELD (DIMETHICONE) LOTION [MEDLINE INDUSTRIES, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RREMEDY NUTRASHIELD (DIMETHICONE) LOTION [MEDLINE INDUSTRIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-157REMEDY NUTRASHIELD (DIMETHICONE) LOTION [MEDLINE INDUSTRIES, LP]12Current NDC, Legacy NDC, 6 package rows20241204_ed8a08a7-594c-46e2-b70f-b75b2960141f.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.

Matched openFDA labels page 5 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fresh Scent PROTECTIVE BABYZINC OXIDECVS Pharmacy, Inc.3f33c62c-43ec-4576-a24d-bd5de07e74d22026-07-23WarningsExact identifier
application number: M016
DERMFREE Vein Target Microneedle PatchALLANTOIN 1% VEIN TARGET MICRONEEDLE PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.57449e29-ec46-9c30-e063-6394a90a7b4a2026-07-23WarningsExact identifier
application number: M016
Baby Vitamin A and DLANOLIN 15.5%, PETROLATUM 53.4%Walgreen Company25a125ea-6f9f-310c-e063-6394a90acef22026-07-22WarningsExact identifier
application number: M016
First Aid A and DLANOLIN 15.5%, PETROLATUM 53.4%Walgreen Company25a319d0-d39a-5ff0-e063-6394a90a671d2026-07-22WarningsExact identifier
application number: M016
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC57110309-9a3d-025f-e063-6394a90a015a2026-07-22WarningsExact identifier
application number: M016
DermasporinLANOLINMarie's Original Formulas LLC562f40aa-eeec-2b7c-e063-6294a90ad68d2026-07-22WarningsExact identifier
application number: M016
CAREALL Vitamin A and DPETROLATUMNew World Imports, Incef89a68a-74c1-4c42-8078-b7a208ace0de2026-07-22WarningsExact identifier
application number: M016
DermactLANOLINMarie's Original Formulas LLC57121dbe-e886-a562-e063-6294a90a367f2026-07-22WarningsExact identifier
application number: M016
Universal WITCH HAZELWITCH HAZELUniversal Distribution Center LLC7e0b56ef-fa41-4862-b387-5b58d81d67d42026-07-22WarningsExact identifier
application number: M016
Aveeno Soothing Bath TreatmentOATMEALKenvue Brands LLC0c410b8e-025f-477c-afac-6e2e9ac88f7d2026-07-21WarningsExact identifier
application number: M016
DERMFREE SCAR SHEETSSILICONE GEL 1% SCAR SHEETSJiangxi Yudexi Pharmaceutical Co., LTD4a4ce316-4b92-7e81-e063-6294a90af6db2026-07-21WarningsExact identifier
application number: M016
DERMFREE VARICOSE VEINSDIMETHICONE 3% VARICOSE VEINSJiangxi Yudexi Pharmaceutical Co., LTD4a5a2d1d-9e84-18eb-e063-6394a90a97ee2026-07-21WarningsExact identifier
application number: M016
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC571083ce-cd35-a638-e063-6394a90ae4c72026-07-20WarningsExact identifier
application number: M016
Mederma Stretch Marks TherapyDIMETHICONEPMI Branded Pharmaceuticals, Inc.0f2918e3-9615-40e3-ab7e-6bfbe022e03c2026-07-16WarningsExact identifier
application number: M016
CalamineFERRIC OXIDE REDBetter Living Brands, LLCc7ef0ef3-6861-4b94-af4b-371fee8c1f3d2026-07-16Warnings, Adverse reactionsExact identifier
application number: M016
DoveMEN CARE ANTIBACTERIAL CARE MOISTURIZING CREAM BARConopco d/b/a Unilever56bd6fcb-c762-4e5a-e063-6394a90a34382026-07-16WarningsExact identifier
application number: M016
Mederma Advanced ScarALLANTOINPMI Branded Pharmaceuticals, Inc.25bc1eae-3502-4c63-bd8a-43be2dfb0d6d2026-07-16WarningsExact identifier
application number: M016
Mederma Advanced ScarALLANTOINL. Perrigo Company9c3d9e08-9428-4b28-82a2-0cb24c3c92a32026-07-16WarningsExact identifier
application number: M016
aftershaveCERAMIDE NPShengnan (Guangzhou) Cosmetics Co., LTD56a17ac9-803b-932c-e063-6394a90aae902026-07-15WarningsExact identifier
application number: M016
Clear Root Labs Wound CareCRL WOUND CARE OINTMENTAidance Scientific Inc. DBA Aidance Skincare & Topicals56a6dbc7-5001-c095-e063-6294a90a1aa02026-07-15WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199680dimethicone 1 % Topical LotionPSNed8a08a7-594c-46e2-b70f-b75b2960141f13
199680dimethicone 10 MG/ML Topical LotionSCDed8a08a7-594c-46e2-b70f-b75b2960141f13
199680dimethicone 1 % Topical LotionSYed8a08a7-594c-46e2-b70f-b75b2960141f13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-157-02533290157023 TUBE in 1 BAG (53329-157-02) / 118 mL in 1 TUBE (53329-157-04) 3 tube2021-07-010000-00-00NoNoCurrent
53329-157-0453329015704118 mL in 1 TUBE (53329-157-04) 118 ml2018-10-100000-00-00NoNoCurrent
53329-157-135332901571359 mL in 1 TUBE (53329-157-13) 59 ml2018-10-100000-00-00NoNoCurrent
53329-157-77533290157774 mL in 1 PACKET (53329-157-77) 4 ml2005-06-010000-00-00NoNoCurrent
53329-157-9653329015796144 PACKET in 1 BOX (53329-157-96) > 4 mL in 1 PACKET144 packet2018-10-100000-00-00NoNoCurrent