RODAN and FIELDS SOOTHE

Product NDC
54111-123
Requested package NDC
54111-123-50
11-digit product format
541110123
Labeler code
54111
Product ID
54111-123_fa350899-cc60-4e64-823e-26da675a2c48
Type
HUMAN OTC DRUG
Nonproprietary name
ALLANTOIN, DIMETHICONE
Dosage form
CREAM
Route
TOPICAL
Labeler
Bentley Laboratories, LLC
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-02-05
Marketing end
0000-00-00
Substance
ALLANTOIN; DIMETHICONE
Active strength
0 g/50mL; g/50mL
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage54111-12354111-123-50DDiscontinued by firm2026-10-05

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALLANTOINACTIVE INGREDIENT344S277G0ZRODAN AND FIELDS SOOTHE (ALLANTOIN, DIMETHICONE) CREAM [BENTLEY LABORATORIES, LLC]1
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1ORODAN AND FIELDS SOOTHE (ALLANTOIN, DIMETHICONE) CREAM [BENTLEY LABORATORIES, LLC]1
ALLANTOINACTIVE MOIETY344S277G0ZRODAN AND FIELDS SOOTHE (ALLANTOIN, DIMETHICONE) CREAM [BENTLEY LABORATORIES, LLC]1
DIMETHICONEACTIVE MOIETY92RU3N3Y1ORODAN AND FIELDS SOOTHE (ALLANTOIN, DIMETHICONE) CREAM [BENTLEY LABORATORIES, LLC]1
1,2-HEXANEDIOLINACTIVE INGREDIENTTR046Y3K1GRODAN AND FIELDS SOOTHE (ALLANTOIN, DIMETHICONE) CREAM [BENTLEY LABORATORIES, LLC]1
ANGELICA POLYMORPHA ROOTINACTIVE INGREDIENTHZ12173363RODAN AND FIELDS SOOTHE (ALLANTOIN, DIMETHICONE) CREAM [BENTLEY LABORATORIES, LLC]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RARODAN AND FIELDS SOOTHE (ALLANTOIN, DIMETHICONE) CREAM [BENTLEY LABORATORIES, LLC]1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438URODAN AND FIELDS SOOTHE (ALLANTOIN, DIMETHICONE) CREAM [BENTLEY LABORATORIES, LLC]1
CHAMOMILEINACTIVE INGREDIENTFGL3685T2XRODAN AND FIELDS SOOTHE (ALLANTOIN, DIMETHICONE) CREAM [BENTLEY LABORATORIES, LLC]1
CHLORHEXIDINE GLUCONATEINACTIVE INGREDIENTMOR84MUD8ERODAN AND FIELDS SOOTHE (ALLANTOIN, DIMETHICONE) CREAM [BENTLEY LABORATORIES, LLC]1
CHLORPHENESININACTIVE INGREDIENTI670DAL4SZRODAN AND FIELDS SOOTHE (ALLANTOIN, DIMETHICONE) CREAM [BENTLEY LABORATORIES, LLC]1
COCO-CAPRYLATE/CAPRATEINACTIVE INGREDIENT8D9H4QU99HRODAN AND FIELDS SOOTHE (ALLANTOIN, DIMETHICONE) CREAM [BENTLEY LABORATORIES, LLC]1
DECYL GLUCOSIDEINACTIVE INGREDIENTZ17H97EA6YRODAN AND FIELDS SOOTHE (ALLANTOIN, DIMETHICONE) CREAM [BENTLEY LABORATORIES, LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXRODAN AND FIELDS SOOTHE (ALLANTOIN, DIMETHICONE) CREAM [BENTLEY LABORATORIES, LLC]1
HEXYLENE GLYCOLINACTIVE INGREDIENTKEH0A3F75JRODAN AND FIELDS SOOTHE (ALLANTOIN, DIMETHICONE) CREAM [BENTLEY LABORATORIES, LLC]1
HONEYINACTIVE INGREDIENTY9H1V576FHRODAN AND FIELDS SOOTHE (ALLANTOIN, DIMETHICONE) CREAM [BENTLEY LABORATORIES, LLC]1
HYDROGENATED POLYBUTENE (1300 MW)INACTIVE INGREDIENT7D1YQ9Y5EZRODAN AND FIELDS SOOTHE (ALLANTOIN, DIMETHICONE) CREAM [BENTLEY LABORATORIES, LLC]1
HYDROGENATED SOYBEAN LECITHININACTIVE INGREDIENTH1109Z9J4NRODAN AND FIELDS SOOTHE (ALLANTOIN, DIMETHICONE) CREAM [BENTLEY LABORATORIES, LLC]1
INDIAN FRANKINCENSEINACTIVE INGREDIENT4PW41QCO2MRODAN AND FIELDS SOOTHE (ALLANTOIN, DIMETHICONE) CREAM [BENTLEY LABORATORIES, LLC]1
ISODODECANEINACTIVE INGREDIENTA8289P68Y2RODAN AND FIELDS SOOTHE (ALLANTOIN, DIMETHICONE) CREAM [BENTLEY LABORATORIES, LLC]1
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H8RODAN AND FIELDS SOOTHE (ALLANTOIN, DIMETHICONE) CREAM [BENTLEY LABORATORIES, LLC]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62RODAN AND FIELDS SOOTHE (ALLANTOIN, DIMETHICONE) CREAM [BENTLEY LABORATORIES, LLC]1
LEVOMENOLINACTIVE INGREDIENT24WE03BX2TRODAN AND FIELDS SOOTHE (ALLANTOIN, DIMETHICONE) CREAM [BENTLEY LABORATORIES, LLC]1
LINOLEIC ACIDINACTIVE INGREDIENT9KJL21T0QJRODAN AND FIELDS SOOTHE (ALLANTOIN, DIMETHICONE) CREAM [BENTLEY LABORATORIES, LLC]1
MICAINACTIVE INGREDIENTV8A1AW0880RODAN AND FIELDS SOOTHE (ALLANTOIN, DIMETHICONE) CREAM [BENTLEY LABORATORIES, LLC]1
PEG-40 STEARATEINACTIVE INGREDIENTECU18C66Q7RODAN AND FIELDS SOOTHE (ALLANTOIN, DIMETHICONE) CREAM [BENTLEY LABORATORIES, LLC]1
PELARGONIUM GRAVEOLENS FLOWER OILINACTIVE INGREDIENT3K0J1S7QGCRODAN AND FIELDS SOOTHE (ALLANTOIN, DIMETHICONE) CREAM [BENTLEY LABORATORIES, LLC]1
PERILLA FRUTESCENS SEED OILINACTIVE INGREDIENT322MS57V7ZRODAN AND FIELDS SOOTHE (ALLANTOIN, DIMETHICONE) CREAM [BENTLEY LABORATORIES, LLC]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TRODAN AND FIELDS SOOTHE (ALLANTOIN, DIMETHICONE) CREAM [BENTLEY LABORATORIES, LLC]1
POLYGLYCERYL-10 STEARATEINACTIVE INGREDIENT90TF85HH91RODAN AND FIELDS SOOTHE (ALLANTOIN, DIMETHICONE) CREAM [BENTLEY LABORATORIES, LLC]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4RODAN AND FIELDS SOOTHE (ALLANTOIN, DIMETHICONE) CREAM [BENTLEY LABORATORIES, LLC]1
RICE BRANINACTIVE INGREDIENTR60QEP13ICRODAN AND FIELDS SOOTHE (ALLANTOIN, DIMETHICONE) CREAM [BENTLEY LABORATORIES, LLC]1
SODIUM ACRYLATEINACTIVE INGREDIENT7C98FKB43HRODAN AND FIELDS SOOTHE (ALLANTOIN, DIMETHICONE) CREAM [BENTLEY LABORATORIES, LLC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EURODAN AND FIELDS SOOTHE (ALLANTOIN, DIMETHICONE) CREAM [BENTLEY LABORATORIES, LLC]1
SOYBEAN GERMINACTIVE INGREDIENTJBW2VHD14MRODAN AND FIELDS SOOTHE (ALLANTOIN, DIMETHICONE) CREAM [BENTLEY LABORATORIES, LLC]1
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YIRODAN AND FIELDS SOOTHE (ALLANTOIN, DIMETHICONE) CREAM [BENTLEY LABORATORIES, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRODAN AND FIELDS SOOTHE (ALLANTOIN, DIMETHICONE) CREAM [BENTLEY LABORATORIES, LLC]1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8RODAN AND FIELDS SOOTHE (ALLANTOIN, DIMETHICONE) CREAM [BENTLEY LABORATORIES, LLC]1
TRANEXAMIC ACIDINACTIVE INGREDIENT6T84R30KC1RODAN AND FIELDS SOOTHE (ALLANTOIN, DIMETHICONE) CREAM [BENTLEY LABORATORIES, LLC]1
TROPOLONEINACTIVE INGREDIENT7L6DL16P1TRODAN AND FIELDS SOOTHE (ALLANTOIN, DIMETHICONE) CREAM [BENTLEY LABORATORIES, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RRODAN AND FIELDS SOOTHE (ALLANTOIN, DIMETHICONE) CREAM [BENTLEY LABORATORIES, LLC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEERODAN AND FIELDS SOOTHE (ALLANTOIN, DIMETHICONE) CREAM [BENTLEY LABORATORIES, LLC]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54111-123-505411101235050 mL in 1 TUBE (54111-123-50) 50 ml2010-02-050000-00-00NoNoCurrent