FDA.reportPublic FDA data

Skin Relief

Product NDC
0363-5995
11-digit product format
003635995
Labeler code
0363
Product ID
0363-5995_50ec2086-3977-67e8-e063-6294a90a82a7
Type
HUMAN OTC DRUG
Nonproprietary name
Lotion
Dosage form
LOTION
Route
TOPICAL
Labeler
Walgreen
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-09-11
Substance
DIMETHICONE
Active strength
1200 mg/100mL
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
Skin Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE1200 mg/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
876980Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fc678e80-e63d-e3fe-e053-6394a90aa7d6Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-5995-18Skin Relief532 mL in 1 BOTTLE, PLASTICLOTION5325

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-5995SKIN RELIEF (LOTION) LOTION [WALGREEN]3Current NDC, 1 package rows20240712_fc678e80-e63d-e3fe-e053-6394a90aa7d6.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 19 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalamineFERRIC OXIDE REDPerrigo Direct, Inc256bd1d4-fd50-408f-9aee-84f218bb49712026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMPerrigo Direct, Ince11470b2-80d6-4008-b87e-eb6aeadfce742026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
Clear Anti-ItchPRAMOXINE HCL, ZINC ACETATEPerrigo Direct, Inccc0378f2-6d5f-47ec-b16a-64668b4c29cc2026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE, PRAMOXIND HCLPerrigo Direct, Inc54a20ec9-ab86-4410-af94-e04393e9d4b32026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
Vitamin A DLANOLIN, PETROLATUMMeijer, Inc.adc3bb9b-ed8a-4b65-b44c-1d1e978c89ec2026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDEMeijer, Inc.1b72f927-c2ae-4190-a035-5d7bb9f53c152026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
Petroleum Skin ProtectantWHITE PETROLATUMMeijer, Inc.af293cc0-ccd5-42a6-861b-c19fa6ffd06a2026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
Healing for BabiesPETROLATUMMeijer, Inc.09878fe0-0890-4af3-a3f6-d2890041e9f82026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
Clear Anti-ItchPRAMOXINE HCL, ZINC ACETATEMeijer, Inc.fa8ae34c-7b68-454f-8a3b-0eaa93a340922026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
Baby Diaper RashZINC OXIDEMeijer, Inc.04bec667-a11e-42d2-a4b3-1416eebf1e8d2026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
HealingPETROLATUMMeijer, Inc.8cb56ee4-b9d1-4a29-88c7-e6f3ac2112c12026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE, PRAMOXINE HCLMeijer, Inc.6b369ef2-fd54-4931-a9eb-0fb42834c2ef2026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
DimethiconeDIMETHICONEMeijer, Inc.75b91b97-ea84-4c4d-9e58-5a9ff27a778c2026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
Colloidal oatmealCOLLOIDAL OATMEALMeijer, Inc.d36a7479-7b3b-49fe-8144-b5cce0e173fb2026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
Daily MoisturizingDAILY MOISTURIZINGMeijer, Inc.44949b46-70f2-4e52-adba-a8455da614eb2026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
Witch HazelWITCH HAZELMeijer, Inc.13e4aece-5b91-4f89-a912-540bf170a8d12026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDETarget Corporation7fb5f9ca-cd90-4933-9fe8-907ece00458b2026-02-18Warnings, Adverse reactionsExact identifier
application number: M016
CalamineFERRIC OXIDE REDTarget Corporationd4ee05c8-ae62-45df-8783-1ed57fa030ec2026-02-18Warnings, Adverse reactionsExact identifier
application number: M016
Pure petroleumWHITE PETROLATUMTarget Corporation5237c7f2-7135-4558-a758-4fc2a232172f2026-02-18Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMTarget Corporation3e620e4f-9e29-9e39-e063-6394a90adeda2026-02-18Warnings, Adverse reactionsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876980dimethicone 1.2 % Topical LotionPSNfc678e80-e63d-e3fe-e053-6394a90aa7d65
876980dimethicone 12 MG/ML Topical LotionSCDfc678e80-e63d-e3fe-e053-6394a90aa7d65
876980dimethicone 1.2 % Topical LotionSYfc678e80-e63d-e3fe-e053-6394a90aa7d65

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-5995-1800363599518532 mL in 1 BOTTLE, PLASTIC (0363-5995-18) 532 ml2023-09-11NoNoCurrent