FDA.reportPublic FDA data

Sarna

Product NDC
0316-0256
11-digit product format
003160256
Labeler code
0316
Product ID
0316-0256_483418a9-057e-f63f-e063-6294a90a4f38
Type
HUMAN OTC DRUG
Nonproprietary name
Colloidal Oatmeal
Dosage form
LOTION
Route
TOPICAL
Labeler
Crown Laboratories, Inc.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-12
Substance
OATMEAL
Active strength
20 mg/mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
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
Sarna
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OATMEAL20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8PI54V663YInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1591951Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2d6b1872-9f4d-9eb3-e063-6394a90ab675Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0316-0256-17Sarna5 mL in 1 TUBELOTION53
0316-0256-75Sarna222 mL in 1 TUBELOTION2223

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0316-0256-75ML - Milliliter0316-02563a385df1-a661-4b69-b2ea-71313d493cfa12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0316-0256SARNA (COLLOIDAL OATMEAL) LOTION [CROWN LABORATORIES, INC.]1Current NDC, 2 package rows20250209_2d6b1872-9f4d-9eb3-e063-6394a90ab675.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 32 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EELHOE Skin Advanced Mole Remove SerumGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.3efd75f9-438a-f811-e063-6394a90a94502025-11-27WarningsExact identifier
application number: M016
EELHOE Wart RemoverGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.3127d616-1933-e783-e063-6294a90a52f72025-11-27WarningsExact identifier
application number: M016
EELHOE Tanning MistGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.32670243-957d-3a95-e063-6394a90a58932025-11-27WarningsExact identifier
application number: M016
EELHOE Skin Tag PatchesGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.3ddd3fb0-b824-0cde-e063-6394a90aea6a2025-11-27WarningsExact identifier
application number: M016
WART REMOVERGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.3fd47677-52c9-6d43-e063-6294a90aa45b2025-11-27WarningsExact identifier
application number: M016
JAYSUING Hair Treatment Green GingerGLYCERINShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.2e8e70de-a2e0-7a71-e063-6294a90a90b82025-11-27WarningsExact identifier
application number: M016
JAYSUING Liquid Wart FlatGLYCERINShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.3b0c05d1-a00e-97df-e063-6394a90af3d02025-11-27WarningsExact identifier
application number: M016
JAYSUING 7 Days Nail Fungus TreatmentGLYCERINShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.2ef424cc-815a-b331-e063-6394a90aae702025-11-27WarningsExact identifier
application number: M016
JAYSUING Pain Relief Knee PatchesGLYCERINShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.358a3e81-abb5-0a65-e063-6294a90a3d692025-11-27WarningsExact identifier
application number: M016
Sandra Plasencia PDRN Rejuvenating SerumRH-OLIGOPEPTIDE-1Guangzhou Meijiao Medical Biotechnology Co., Ltd.449634c8-ff99-1387-e063-6294a90aef452025-11-27WarningsExact identifier
application number: M016
GLUTATHIONEKOJIC ACIDSKIN LIGHTENINGHANCHOYEANBIOTEC Co.,Ltd.2be274be-e6d0-d961-e063-6294a90a21902025-11-27WarningsExact identifier
application number: M016
XIMONTH Bee Venom Joint CreamGLYCERINShantou Ximonth Biotechnology Co., Ltd.33d18888-8d06-da13-e063-6294a90a743c2025-11-26WarningsExact identifier
application number: M016
XIMONTH Bee Venom Wart Remover PatchGLYCERINShantou Ximonth Biotechnology Co., Ltd.3e6965b6-8f08-db62-e063-6394a90a64c92025-11-26WarningsExact identifier
application number: M016
XIMONTH GLP-1 PatchesGLYCERINShantou Ximonth Biotechnology Co., Ltd.3d03cdfd-2e9e-f9a1-e063-6394a90a6a8b2025-11-26WarningsExact identifier
application number: M016
XIMONTH Bee Venom RepairGLYCERINShantou Ximonth Biotechnology Co., Ltd.37e40cc1-1121-1eee-e063-6294a90aab262025-11-26WarningsExact identifier
application number: M016
XIMONTH Liquid Wart Corn Callus RemoverGLYCERINShantou Ximonth Biotechnology Co., Ltd.3a1b872a-2883-0b70-e063-6294a90af9d62025-11-26WarningsExact identifier
application number: M016
XIMONTH Jimerito Honey For EyesGLYCERINShantou Ximonth Biotechnology Co., Ltd.3aa38704-4d2b-ffaf-e063-6294a90a323e2025-11-26WarningsExact identifier
application number: M016
XIMONTH Bee Honey Eye DropsGLYCERINShantou Ximonth Biotechnology Co., Ltd.3e69c950-bbbc-5c47-e063-6294a90a070e2025-11-26WarningsExact identifier
application number: M016
BoudreauxsZINC OXIDEC.B. Fleet Company, Inc.4c7e832e-55f3-4766-98b7-29b17d741a4b2025-11-26WarningsExact identifier
application number: M016
Johnsons Baby Care Essentials Gift SetZINC OXIDEKenvue Brands LLC43edc287-57e1-d96e-e063-6294a90ac5a12025-11-24WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1591951colloidal oatmeal 2 % Topical LotionPSN2d6b1872-9f4d-9eb3-e063-6394a90ab6753
1591951colloidal oatmeal 20 MG/ML Topical LotionSCD2d6b1872-9f4d-9eb3-e063-6394a90ab6753
1591951colloidal oatmeal 2 % Topical LotionSY2d6b1872-9f4d-9eb3-e063-6394a90ab6753

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0316-0256-17003160256175 mL in 1 TUBE (0316-0256-17) 5 ml2025-11-11YesNoCurrent
0316-0256-7500316025675222 mL in 1 TUBE (0316-0256-75) 222 ml2025-01-12NoNoCurrent