FDA.reportPublic FDA data

SOOTHE Sensitive Skin Treatment

Product NDC
14222-2420
11-digit product format
142222420
Labeler code
14222
Product ID
14222-2420_bbb80b31-6ecc-4d23-a2c3-784c6ea2289c
Type
HUMAN OTC DRUG
Nonproprietary name
Allantoin, Dimethicone
Dosage form
LOTION
Route
TOPICAL
Labeler
Rodan & Fields
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-03-09
Substance
ALLANTOIN; DIMETHICONE
Active strength
.5; 2 g/100mL; g/100mL
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SOOTHE Sensitive Skin Treatment
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALLANTOIN.5 g/100mL
DIMETHICONE2 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii344S277G0Z, 92RU3N3Y1O

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
14222-2420-12022-12-27C16284748780-1e4f33bdf-ae8d-d8a0-e053-dadaa90a6e4eDrug Facts
14222-2420-12022-07-29C16284748780-1e4f33bdf-ae8d-d8a0-e053-dadaa90a6e4eDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14222-2420-1SOOTHE Sensitive Skin Treatment50 mL in 1 BOTTLELOTION504
14222-2420-1SOOTHE Sensitive Skin Treatment1 in 1 CARTONLOTION14
14222-2420-2SOOTHE Sensitive Skin Treatment1 in 1 CARTONLOTION14
14222-2420-2SOOTHE Sensitive Skin Treatment10 mL in 1 TUBELOTION104
14222-2420-3SOOTHE Sensitive Skin Treatment2 mL in 1 PACKETLOTION24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14222-2420SOOTHE SENSITIVE SKIN TREATMENT (ALLANTOIN, DIMETHICONE) LOTION [RODAN & FIELDS]4Current NDC, Legacy NDC, 5 package rows20241213_2bd8cac4-5f40-4d04-91f2-3ea8a138033b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
14222-2420-1142222420011 BOTTLE in 1 CARTON (14222-2420-1) / 50 mL in 1 BOTTLE1 bottle2021-03-090000-00-00NoNoCurrent
14222-2420-2142222420021 TUBE in 1 CARTON (14222-2420-2) / 10 mL in 1 TUBE1 tube2021-06-010000-00-00NoNoCurrent
14222-2420-3142222420032 mL in 1 PACKET (14222-2420-3) 2 ml2022-04-120000-00-00NoNoCurrent