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 2 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Petroleum Skin ProtectantWHITE PETROLATUMYour Military Exchanges1a0aed14-8606-4676-b4b5-23dd415d43ac2026-09-02Warnings, Adverse reactionsExact identifier
application number: M016
Aloetouch Protect Fragrance FreeDIMETHICONEMedline Industries, LP81f0071b-2bf3-455b-9e5d-8f3ca20adcdf2026-09-01WarningsExact identifier
application number: M016
PURE PETROLATUMPETROLATUMVASA COSMETICS PRIVATE LIMITED5a57b197-3e18-b3ab-e063-6394a90aed822026-08-31WarningsExact identifier
application number: M016
HYDROPHORHYDROPHORAkron Pharma Inc.e6099df7-d418-479a-9d2e-ced523585aed2026-08-28WarningsExact identifier
application number: M016
Witch HazelWITCH HAZELUnited Natural Foods, Inc. dba UNFId2d1bd9e-7025-4151-95f2-a2f521dc2be82026-08-28Warnings, Adverse reactionsExact identifier
application number: M016
Daily MoisturizingDIMETHICONEYour Military Exchangese7af5488-1c49-41e9-9d8b-d519c61076992026-08-28Warnings, Adverse reactionsExact identifier
application number: M016
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
application number: M016
Estriol CreamESTRIOLGuangxi Keyun E-commerce Co., Ltd.4deadcb6-0d46-bdd7-e063-6294a90a26d72026-08-27WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP0d964138-f68d-dbf5-e063-6294a90a83202026-08-27WarningsExact identifier
application number: M016
Gembooxt ECZEMA RELIEF CreamHYDROCORTISONEGuangdong Quadrant Ecological Technology Co., Ltd.46490d65-f789-eaa2-e063-6294a90a623b2026-08-27WarningsExact identifier
application number: M016
Serawise Eczema ReliefOATMEALDrAnaMaria. Com LLCf0681436-d140-4e02-afe4-5b16de07afcd2026-08-26WarningsExact identifier
application number: M016
Hair Regrowth FoamGLYCERINShantou Ouhoe Technology Co., Ltd.59ef5953-e96f-5707-e063-6294a90a30942026-08-26WarningsExact identifier
application number: M016
Growth TreatmentGLYCERINShantou Ouhoe Technology Co., Ltd.59fe12eb-574f-a199-e063-6394a90abd062026-08-26WarningsExact identifier
application number: M016
Acne ReliefSALICYLIC ACID,NIACINAMIDE,PANTHENOL.Guangzhou Senmai Biotechnology Co.,Ltd.59db0143-de57-59d2-e063-6294a90a32a82026-08-25WarningsExact identifier
application number: M016
Witch HazelWITCH HAZELYour Military Exchanges4079fd56-55f3-4e69-93e0-7590c07fb7942026-08-25Warnings, Adverse reactionsExact identifier
application number: M016
Salicylic Acid Acne Gel CleanserSALICYLIC ACID,PANTHENOLGuangzhou Senmai Biotechnology Co.,Ltd.59eb395b-493b-efc9-e063-6294a90aa8912026-08-25WarningsExact identifier
application number: M016
ClaravieDIMETHICONEGentell LLC59c6da39-b5f1-8253-e063-6394a90a0e8f2026-08-24WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP0d94fd18-a120-e171-e063-6394a90ae9c02026-08-24WarningsExact identifier
application number: M016
MUSTELA Diaper Rash 1 2 3ZINC OXIDEExpanscience Laboratories d/b/a Mustela59cf1d1e-e951-9d58-e063-6394a90af0f32026-08-24WarningsExact identifier
application number: M016
ClaravieZINC OXIDE, DIMETHICONEGentell LLC598a5c0b-1e2f-1335-e063-6394a90ac4f42026-08-21WarningsExact 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