Dynashield with Dimethicone

Product NDC
67777-408
Requested package NDC
67777-408-03
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 1 of 70 · 1,384 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermaka Infants and Kids Multi Purpose Skin ProtectantZINC OXIDEDermaka Skin Products LLCf84dfd55-db6c-4d75-be67-4d13a139e2092026-09-10WarningsExact identifier
application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic MultipurposeDIMETHICONEL'Oreal USA Products Inc805cd262-2689-4818-8fed-ddefacbdde232026-09-10WarningsExact identifier
application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic MultipurposeDIMETHICONECosmetique Active Productiond19f482c-bec7-45aa-b22f-fe91a3dc717d2026-09-10WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDECVS Pharmacy, Inc.35e67726-4527-4cd7-8e73-30325a32402c2026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Lanolin, PetrolatumLANOLIN, PETROLATUMCVS Pharmacy, Inc.606f65a8-08fd-4ab6-9d68-03ddf662bdf02026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Eczema Soothing Moisturizing CreamCOLLOIDAL OATMEALNice-Pak Products, LLC23548524-2e2e-4d1a-9ebb-6f86d6279e932026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMWalgreen Co.22bd8e87-965c-466b-bb9b-7d4753e500bc2026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Drs. pharmacy Scar CreamALLANTOINOL PHARMA TECH, LLC Drs PHARMACYd0381034-8cf7-5e8d-e053-2995a90a9faa2026-09-09WarningsExact identifier
application number: M016
Drs. Pharmacy baby healingPETROLATUMOL PHARMA TECH, LLC Drs PHARMACY5b14ffa0-9486-a7fe-e063-6394a90ab3ed2026-09-09WarningsExact identifier
application number: M016
Wart RemoverGLYCERINShantou Ouhoe Technology Co., Ltd.5af3afe1-dad5-91b7-e063-6294a90ab95e2026-09-08WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP5afb3595-f014-153e-e063-6294a90ad34b2026-09-08WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP5afb59b4-491c-45bb-e063-6294a90a0ae62026-09-08WarningsExact identifier
application number: M016
ClaravieALUMINUM HYDROXIDE GELGentell LLC5afea757-8feb-f907-e063-6394a90a62592026-09-08WarningsExact identifier
application number: M016
Clear Anti ItchPRAMOXINE HCL, ZINC ACETATEUnited Natural Foods, Inc. dba UNFI242adc68-f9e0-4f69-a580-a107d1634b502026-09-04Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
application number: M016
FIRST AID BEAUTY FAB ULTRA REPAIR SKIN PROTECTANT KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company5a9aaca8-474a-0393-e063-6394a90a5a3a2026-09-04WarningsExact identifier
application number: M016
Aveeno Eczema Therapy CreamCOLLOIDAL OATMEALKenvue Brands LLC5a7b0470-3ed5-5b92-e063-6294a90ae0f42026-09-03WarningsExact identifier
application number: M016
First Aid Beauty Face and Body Bestsellers KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company5a974dbf-84ac-5374-e063-6294a90a8da02026-09-03WarningsExact identifier
application number: M016
Pure Petrolatum JellyPETROLATUMJell Pharmaceuticals Pvt. Ltd.cdc297cb-476a-6da9-e053-2a95a90a399a2026-09-02WarningsExact identifier
application number: M016
Nail Treatment LiquidGLYCERINShantou Ximonth Biotechnology Co., Ltd.5a7cd607-a50e-17d0-e063-6294a90acdb22026-09-02WarningsExact 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
67777-408-0367777040803114 g in 1 TUBE (67777-408-03) 114 g2014-10-010000-00-00NoNoCurrent