FDA.reportPublic FDA data

Dynashield with Dimethicone

Product NDC
67777-408
11-digit product format
677770408
Labeler code
67777
Product ID
67777-408_4df28dab-75de-50c0-e063-6394a90adbbc
Type
HUMAN OTC DRUG
Nonproprietary name
zinc oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Dynarex Corporation
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-10-01
Substance
DIMETHICONE; ZINC OXIDE
Active strength
1.8; 2 g/100g; g/100g
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
Dynashield with Dimethicone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE1.8 g/100g
ZINC OXIDE2 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
92RU3N3Y1OInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2644139Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b5dcf9e8-4689-4a08-ae73-3a859b4cbffeAvailable on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-408-02Dynashield with Dimethicone24 in 1 CASECREAM248
67777-408-03Dynashield with Dimethicone114 g in 1 TUBECREAM1148
67777-408-05Dynashield with Dimethicone144 in 1 BOXCREAM1448
67777-408-05Dynashield with Dimethicone5 g in 1 PACKETCREAM58
67777-408-06Dynashield with Dimethicone2 in 1 CASECREAM28

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67777-408-02GM - Gram67777-4081edea491-5ddf-44fb-ad2b-d590e15d47bf12026-01-08
67777-408-03GM - Gram67777-40883a58bf9-6506-4873-afbf-a6583bfe609312026-01-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1ODYNASHIELD WITH DIMETHICONE (ZINC OXIDE) OINTMENT [DYNAREX CORPORATION]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZDYNASHIELD WITH DIMETHICONE (ZINC OXIDE) OINTMENT [DYNAREX CORPORATION]1
DIMETHICONEACTIVE MOIETY92RU3N3Y1ODYNASHIELD WITH DIMETHICONE (ZINC OXIDE) OINTMENT [DYNAREX CORPORATION]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZDYNASHIELD WITH DIMETHICONE (ZINC OXIDE) OINTMENT [DYNAREX CORPORATION]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XDYNASHIELD WITH DIMETHICONE (ZINC OXIDE) OINTMENT [DYNAREX CORPORATION]1
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1DYNASHIELD WITH DIMETHICONE (ZINC OXIDE) OINTMENT [DYNAREX CORPORATION]1
CETETH-20INACTIVE INGREDIENTI835H2IHHXDYNASHIELD WITH DIMETHICONE (ZINC OXIDE) OINTMENT [DYNAREX CORPORATION]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SDYNASHIELD WITH DIMETHICONE (ZINC OXIDE) OINTMENT [DYNAREX CORPORATION]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNDYNASHIELD WITH DIMETHICONE (ZINC OXIDE) OINTMENT [DYNAREX CORPORATION]1
CHOLECALCIFEROLINACTIVE INGREDIENT1C6V77QF41DYNASHIELD WITH DIMETHICONE (ZINC OXIDE) OINTMENT [DYNAREX CORPORATION]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDYNASHIELD WITH DIMETHICONE (ZINC OXIDE) OINTMENT [DYNAREX CORPORATION]1
LANOLININACTIVE INGREDIENT7EV65EAW6HDYNASHIELD WITH DIMETHICONE (ZINC OXIDE) OINTMENT [DYNAREX CORPORATION]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TDYNASHIELD WITH DIMETHICONE (ZINC OXIDE) OINTMENT [DYNAREX CORPORATION]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPDYNASHIELD WITH DIMETHICONE (ZINC OXIDE) OINTMENT [DYNAREX CORPORATION]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UDYNASHIELD WITH DIMETHICONE (ZINC OXIDE) OINTMENT [DYNAREX CORPORATION]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHDYNASHIELD WITH DIMETHICONE (ZINC OXIDE) OINTMENT [DYNAREX CORPORATION]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKDYNASHIELD WITH DIMETHICONE (ZINC OXIDE) OINTMENT [DYNAREX CORPORATION]1
VITAMIN AINACTIVE INGREDIENT81G40H8B0TDYNASHIELD WITH DIMETHICONE (ZINC OXIDE) OINTMENT [DYNAREX CORPORATION]1
WATERINACTIVE INGREDIENT059QF0KO0RDYNASHIELD WITH DIMETHICONE (ZINC OXIDE) OINTMENT [DYNAREX CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-408DYNASHIELD WITH DIMETHICONE (ZINC OXIDE) CREAM [DYNAREX CORPORATION]7Current NDC, Legacy NDC, 5 package rows20241122_b5dcf9e8-4689-4a08-ae73-3a859b4cbffe.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 9 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUPRADERMWHITE PETROLATUM, LANOLINOlen Skin Care Corporation4e7199bd-52c6-48e9-9c78-c84e45412faf2026-06-10WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP509ee758-9d53-220c-e063-6394a90a4bd52026-06-09WarningsExact identifier
application number: M016
BABY BUM DIAPERZINC OXIDECreative Consumer Products, Inc. DBA (Doing Business As) Dionis Goat Milk Skincare53d8a654-aaec-6f91-e063-6394a90a73512026-06-09WarningsExact identifier
application number: M016
CELISTAR MICRONEEDLING INFUSIONHYALURONATE SODIUMGuangdong Outeli Biotechnology Co., Ltd.53de46a7-3947-70a7-e063-6294a90ab8292026-06-09WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP3c448cf7-8ca5-c7f7-e063-6294a90a75ff2026-06-08WarningsExact identifier
application number: M016
WOODSLEEP Wild Yam CreamGLYCERINShantou Woodsleep Biotechnology Co., Ltd.53b992fd-5759-57bb-e063-6394a90a16002026-06-08WarningsExact identifier
application number: M016
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
application number: M016
GNP Calamine Topical SuspensionCALAMINE 8% AND ZINC OXIDE 8%Amerisource Bergen777b0e66-1bce-4483-9dad-c46796fd6f232026-06-04WarningsExact identifier
application number: M016
GNP CaldyphenCALAMINE AND PRAMOXINE HYDROCHLORIDEAmerisource Bergen515c58d7-0dc4-45e7-9155-e5270a16290e2026-06-04WarningsExact identifier
application number: M016
First Aid Beauty Sensitive Skin Bestsellers KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company535a0e8e-6bb4-6652-e063-6394a90aa7ff2026-06-03WarningsExact identifier
application number: M016
Quad WashDIMETHICONEDynarex Corporation535dc862-6a18-26c9-e063-6294a90a3d4a2026-06-03WarningsExact identifier
application number: M016
First Aid Beauty Sensitive Skin Bestsellers KitCOLLOIDAL OATMEALJCS Global Distribution, Inc.535e42a1-8b14-324d-e063-6394a90a3f652026-06-03WarningsExact identifier
application number: M016
Petroleum Jelly Skin ProtectantWHITE PETROLATUMAcme United Corporation535e94bb-21e8-90be-e063-6394a90a37bb2026-06-03WarningsExact identifier
application number: M016
ADVANCED HEALINGPETROLATUMRejoice International Corp.532c7e5a-4d05-3bd0-e063-6294a90aee002026-06-01WarningsExact identifier
application number: M016
PUTRIZEN 40 UREAGLYCERINShantou Ximonth Biotechnology Co., Ltd.533dadbc-6f20-d880-e063-6394a90a753f2026-06-01WarningsExact identifier
application number: M016
ADVANCED HEALING BALMPETROLATUMRejoice International Corp.53285d82-3755-ca78-e063-6394a90a50192026-05-31WarningsExact identifier
application number: M016
KIEHLS SINCE 1851 Ultra Facial Meltdown RecoveryCOLLOIDAL OATMEALLOreal USA Products Inc22e088b9-b3b1-4c34-be12-a5a31200ec252026-05-29WarningsExact identifier
application number: M016
Acne Relief CreamNIACINAMIDE,SALICYLIC ACID,CENTELLA ASIATICA ROOT,COPTIS CHINENSIS ROOTGuangzhou Senmai Biotechnology Co.,Ltd.53008b89-89ab-7650-e063-6294a90ac16c2026-05-29WarningsExact identifier
application number: M016
PURE PETROLATUMPETROLATUMVASA COSMETICS PRIVATE LIMITED52efd466-49bd-bbdf-e063-6394a90aa1082026-05-28WarningsExact identifier
application number: M016
TheraCare Vitamin A and D plus EPETROLATUMVeridian Healthcare52e0e248-6c04-feb9-e063-6394a90add462026-05-28WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2644139dimethicone 1.8 % / zinc oxide 2 % Topical CreamPSNb5dcf9e8-4689-4a08-ae73-3a859b4cbffe8
2644139dimethicone 18 MG/ML / zinc oxide 20 MG/ML Topical CreamSCDb5dcf9e8-4689-4a08-ae73-3a859b4cbffe8
2644139dimethicone 1.8 % / zinc oxide 2 % Topical CreamSYb5dcf9e8-4689-4a08-ae73-3a859b4cbffe8
2644139dimethicone 18 MG/ML / ZNO 20 MG/ML Topical CreamSYb5dcf9e8-4689-4a08-ae73-3a859b4cbffe8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67777-408-026777704080224 TUBE in 1 CASE (67777-408-02) / 114 g in 1 TUBE (67777-408-03) 24 tube2014-10-010000-00-00NoNoCurrent
67777-408-0367777040803114 g in 1 TUBE (67777-408-03) 114 g2014-10-010000-00-00NoNoCurrent
67777-408-0567777040805144 in 1 BOXHistorical
67777-408-06677770408062 BOX in 1 CASE (67777-408-06) / 144 PACKET in 1 BOX (67777-408-05) / 5 g in 1 PACKET2 box2026-03-31NoNoCurrent