Miracle Heel Repair

Product NDC
66391-0604
11-digit product format
663910604
Labeler code
66391
Product ID
66391-0604_d68f0880-cec3-48aa-abc9-cbd9712b2448
Type
HUMAN OTC DRUG
Nonproprietary name
Allantoin , Dimethicone
Dosage form
CREAM
Route
TOPICAL
Labeler
Winning Solutions
Application
part347
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2009-03-16
Marketing end
0000-00-00
Substance
ALLANTOIN; DIMETHICONE
Active strength
1 g/112g; g/112g
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct66391-0604IInactivated by FDA2026-10-05
excluded packagepackage66391-060466391-0604-0IInactivated by FDA2026-10-05

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66391-0604-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66391-0604-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66391-0604-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66391-0604-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66391-0604-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66391-0604-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66391-0604-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66391-0604-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66391-0604-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66391-0604-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage66391-0604-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66391-0604-0557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage66391-0604-08af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage66391-0604-0834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage66391-0604-01332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage66391-0604-0fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage66391-0604-086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage66391-0604-0bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage66391-0604-08dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage66391-0604-0e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage66391-0604-09bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage66391-0604-0110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66391-0604-02019-10-29C16284748780-1960f7f55-c52d-8e05-e053-dbdaa90a074ae296fe75-8a7a-405d-8a21-a2180d2b4922

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66391-0604-0Miracle Heel Repair112 g in 1 TUBECREAM1121

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AllantoinACTIVE INGREDIENT344S277G0ZMIRACLE HEEL REPAIR (ALLANTOIN , DIMETHICONE) CREAM [WINNING SOLUTIONS]1
DimethiconeACTIVE INGREDIENT92RU3N3Y1OMIRACLE HEEL REPAIR (ALLANTOIN , DIMETHICONE) CREAM [WINNING SOLUTIONS]1
AllantoinACTIVE MOIETY344S277G0ZMIRACLE HEEL REPAIR (ALLANTOIN , DIMETHICONE) CREAM [WINNING SOLUTIONS]1
DimethiconeACTIVE MOIETY92RU3N3Y1OMIRACLE HEEL REPAIR (ALLANTOIN , DIMETHICONE) CREAM [WINNING SOLUTIONS]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XMIRACLE HEEL REPAIR (ALLANTOIN , DIMETHICONE) CREAM [WINNING SOLUTIONS]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KMIRACLE HEEL REPAIR (ALLANTOIN , DIMETHICONE) CREAM [WINNING SOLUTIONS]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SMIRACLE HEEL REPAIR (ALLANTOIN , DIMETHICONE) CREAM [WINNING SOLUTIONS]1
Cetyl AlcoholINACTIVE INGREDIENT936JST6JCNMIRACLE HEEL REPAIR (ALLANTOIN , DIMETHICONE) CREAM [WINNING SOLUTIONS]1
CHAMOMILEINACTIVE INGREDIENTFGL3685T2XMIRACLE HEEL REPAIR (ALLANTOIN , DIMETHICONE) CREAM [WINNING SOLUTIONS]1
CHONDRUSINACTIVE INGREDIENTXR12Z4HLEAMIRACLE HEEL REPAIR (ALLANTOIN , DIMETHICONE) CREAM [WINNING SOLUTIONS]1
COCOA BUTTERINACTIVE INGREDIENT512OYT1CRRMIRACLE HEEL REPAIR (ALLANTOIN , DIMETHICONE) CREAM [WINNING SOLUTIONS]1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUMIRACLE HEEL REPAIR (ALLANTOIN , DIMETHICONE) CREAM [WINNING SOLUTIONS]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4MIRACLE HEEL REPAIR (ALLANTOIN , DIMETHICONE) CREAM [WINNING SOLUTIONS]1
MANGOINACTIVE INGREDIENTI629I3NR86MIRACLE HEEL REPAIR (ALLANTOIN , DIMETHICONE) CREAM [WINNING SOLUTIONS]1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TMIRACLE HEEL REPAIR (ALLANTOIN , DIMETHICONE) CREAM [WINNING SOLUTIONS]1
Mineral OilINACTIVE INGREDIENTT5L8T28FGPMIRACLE HEEL REPAIR (ALLANTOIN , DIMETHICONE) CREAM [WINNING SOLUTIONS]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RMIRACLE HEEL REPAIR (ALLANTOIN , DIMETHICONE) CREAM [WINNING SOLUTIONS]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQMIRACLE HEEL REPAIR (ALLANTOIN , DIMETHICONE) CREAM [WINNING SOLUTIONS]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MMIRACLE HEEL REPAIR (ALLANTOIN , DIMETHICONE) CREAM [WINNING SOLUTIONS]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MIRACLE HEEL REPAIR (ALLANTOIN , DIMETHICONE) CREAM [WINNING SOLUTIONS]1
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHMIRACLE HEEL REPAIR (ALLANTOIN , DIMETHICONE) CREAM [WINNING SOLUTIONS]1
SALICYLIC ACIDINACTIVE INGREDIENTO414PZ4LPZMIRACLE HEEL REPAIR (ALLANTOIN , DIMETHICONE) CREAM [WINNING SOLUTIONS]1
SHEA BUTTERINACTIVE INGREDIENTK49155WL9YMIRACLE HEEL REPAIR (ALLANTOIN , DIMETHICONE) CREAM [WINNING SOLUTIONS]1
Stearic AcidINACTIVE INGREDIENT4ELV7Z65APMIRACLE HEEL REPAIR (ALLANTOIN , DIMETHICONE) CREAM [WINNING SOLUTIONS]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKMIRACLE HEEL REPAIR (ALLANTOIN , DIMETHICONE) CREAM [WINNING SOLUTIONS]1
WaterINACTIVE INGREDIENT059QF0KO0RMIRACLE HEEL REPAIR (ALLANTOIN , DIMETHICONE) CREAM [WINNING SOLUTIONS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66391-0604MIRACLE HEEL REPAIR (ALLANTOIN , DIMETHICONE) CREAM [WINNING SOLUTIONS]1Legacy NDC, 1 package rows20110816_e296fe75-8a7a-405d-8a21-a2180d2b4922.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1145955allantoin 1 % / dimethicone 1 % Topical CreamPSNe296fe75-8a7a-405d-8a21-a2180d2b49221
1145955allantoin 10 MG/ML / dimethicone 10 MG/ML Topical CreamSCDe296fe75-8a7a-405d-8a21-a2180d2b49221
1145955allantoin 1 % / dimethicone 1 % Topical CreamSYe296fe75-8a7a-405d-8a21-a2180d2b49221

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
66391-0604-066391060400112 g in 1 TUBE112 gHistorical