FDA.reportPublic FDA data

AmeriDerm

Product NDC
52410-8020
11-digit product format
524108020
Labeler code
52410
Product ID
52410-8020_3c6a8249-6365-a555-e063-6294a90a1ecc
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Shield Line LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-01-01
Substance
ZINC OXIDE
Active strength
3.8 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
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
AmeriDerm
Brand name suffix
PeriShield
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE3.8 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1089065Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
417f1541-d65a-4612-b96b-e6183fbef1f3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
52410-8020-02023-11-01PeriShield
52410-8020-42023-11-01PeriShield
52410-8020-02023-07-28PeriShield
52410-8020-42023-07-28PeriShield

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52410-8020-0AmeriDermPeriShield100 g in 1 TUBEOINTMENT10017
52410-8020-4AmeriDermPeriShield452 g in 1 JAROINTMENT45217

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52410-8020-0GM - Gram52410-802047c5ffff-61d0-447a-b6c9-96afe3b8dc6512017-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZAMERIDERM PERISHIELD (ZINC OXIDE) OINTMENT [SHIELD LINE LLC ]2
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZAMERIDERM PERISHIELD (ZINC OXIDE) OINTMENT [SHIELD LINE LLC ]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XAMERIDERM PERISHIELD (ZINC OXIDE) OINTMENT [SHIELD LINE LLC ]2
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1AMERIDERM PERISHIELD (ZINC OXIDE) OINTMENT [SHIELD LINE LLC ]2
CHLOROXYLENOLINACTIVE INGREDIENT0F32U78V2QAMERIDERM PERISHIELD (ZINC OXIDE) OINTMENT [SHIELD LINE LLC ]2
CHOLECALCIFEROLINACTIVE INGREDIENT1C6V77QF41AMERIDERM PERISHIELD (ZINC OXIDE) OINTMENT [SHIELD LINE LLC ]2
CORN OILINACTIVE INGREDIENT8470G57WFMAMERIDERM PERISHIELD (ZINC OXIDE) OINTMENT [SHIELD LINE LLC ]2
LANOLININACTIVE INGREDIENT7EV65EAW6HAMERIDERM PERISHIELD (ZINC OXIDE) OINTMENT [SHIELD LINE LLC ]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPAMERIDERM PERISHIELD (ZINC OXIDE) OINTMENT [SHIELD LINE LLC ]2
PARAFFININACTIVE INGREDIENTI9O0E3H2ZEAMERIDERM PERISHIELD (ZINC OXIDE) OINTMENT [SHIELD LINE LLC ]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UAMERIDERM PERISHIELD (ZINC OXIDE) OINTMENT [SHIELD LINE LLC ]2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TAMERIDERM PERISHIELD (ZINC OXIDE) OINTMENT [SHIELD LINE LLC ]2
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QOAMERIDERM PERISHIELD (ZINC OXIDE) OINTMENT [SHIELD LINE LLC ]2
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCAMERIDERM PERISHIELD (ZINC OXIDE) OINTMENT [SHIELD LINE LLC ]2
WATERINACTIVE INGREDIENT059QF0KO0RAMERIDERM PERISHIELD (ZINC OXIDE) OINTMENT [SHIELD LINE LLC ]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52410-8020AMERIDERM PERISHIELD (ZINC OXIDE) OINTMENT [SHIELD LINE LLC]16Current NDC, Legacy NDC, 2 package rows20240719_417f1541-d65a-4612-b96b-e6183fbef1f3.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 12 of 68 · 1,346 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVSPETROLATUMApollo Health and Beauty Care47d2b9be-91ad-e9e2-e063-6294a90ac29f2026-04-30WarningsExact identifier
application number: M016
Dr. NumbLIDOCAINEShinpharma Inc0578fbcb-875a-4606-acde-dcecb29756e62026-04-30WarningsExact identifier
application number: M016
Colloidal oatmealCOLLOIDAL OATMEALAmazon.com Services LLC423c821d-92af-47f0-b9ee-8b68ecbcc44e2026-04-29Warnings, Adverse reactionsExact identifier
application number: M016
MICRO INFUSIONSYSTEMSEEK GLONingbo Kenwei International Trade Co., Ltd.50746cab-bfcc-fe0b-e063-6394a90adc012026-04-27WarningsExact identifier
application number: M016
Pharmacy ChoiceMENTHOL, ZINC OXIDEPHARMACY CHOICE INC5031fc05-e1c7-40b1-e063-6394a90aa12c2026-04-24WarningsExact identifier
application number: M016
Sel pH baby PH-BALANCED ECZEMA DRYNESS BABYLOTIONSEL PH BABY PH-BALANCED ECZEMA DRYNESS BABYGuangzhou Ariel Biotech Co., Ltd.5040b707-87af-3859-e063-6294a90afb3d2026-04-24WarningsExact identifier
application number: M016
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
application number: M016
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
application number: M016
Arm and Hammer Baking SodaSODIUM BICARBONATEChurch & Dwight Co., Inc.643fe204-4a7b-00e4-e053-2a91aa0aef062026-04-21WarningsExact identifier
application number: M016
PURE PETROLATUMPETROLATUMMY IMPORTS USA LLC4fba8bc7-590d-f621-e063-6294a90ad8c92026-04-18WarningsExact identifier
application number: M016
Anti-Itch Regular StrengthHYDROCORTISONECVS Pharmacy9fe7768b-9023-c9ee-e053-2a95a90a55b32026-04-17WarningsExact identifier
application number: M016
Calamine ClearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTIONPharma Nobis, LLC4f853183-5925-2c73-e063-6394a90adf6c2026-04-15WarningsExact identifier
application number: M016
Freskaro Calamine PlusZINC OXIDE LOTIONPharma Nobis, LLC4f85bdc7-8fed-f1f5-e063-6394a90a63582026-04-15WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDE OINTMENTDynarex Corporation11d79dd6-35f7-4399-e063-6294a90ac7dd2026-04-13WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC4f261746-37e9-7b30-e063-6294a90a92242026-04-10WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC4f268501-6cd7-7edd-e063-6294a90ac6492026-04-10WarningsExact identifier
application number: M016
BEVERLY HILLS MD HYDRARESCUE TREATMENTDIMETHICONEBeverly Hills MD, LLC4ed33a43-d059-2589-e063-6294a90a30b32026-04-09WarningsExact identifier
application number: M016
Petroleum JellyWHITE PETROLATUMWAL-MART STORES INC00faa772-53f3-9276-e063-6394a90a2dab2026-04-07WarningsExact identifier
application number: M016
ProCure Zinc OxideZINC OXIDETwin Med LLC37a30ee5-fd33-b410-e063-6294a90aef722026-04-07WarningsExact identifier
application number: M016
Colloidal oatmealCOLLOIDAL OATMEALCVS Pharmacy, Inc.4a43b1a2-2156-e490-e063-6294a90a6f842026-04-07Warnings, Adverse reactionsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1089065zinc oxide 3.8 % Topical OintmentPSN417f1541-d65a-4612-b96b-e6183fbef1f317
1089065zinc oxide 0.038 MG/MG Topical OintmentSCD417f1541-d65a-4612-b96b-e6183fbef1f317
1089065ZNO 0.038 MG/MG Topical OintmentSY417f1541-d65a-4612-b96b-e6183fbef1f317

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52410-8020-052410802000100 g in 1 TUBE (52410-8020-0) 100 g2015-01-010000-00-00NoNoCurrent
52410-8020-452410802004452 g in 1 JAR (52410-8020-4) 452 g2015-01-010000-00-00NoNoCurrent