FDA.reportPublic FDA data

Dynashield

Product NDC
67777-407
11-digit product format
677770407
Labeler code
67777
Product ID
67777-407_4e3e4630-9843-775a-e063-6294a90a3ca0
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
ZINC OXIDE
Active strength
1.8 g/100g
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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE1.8 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
1427410Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
59fd865c-b81d-43ad-8fa0-c37ca0557769Available 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
67777-407-01Dynashield5 g in 1 PACKETCREAM510
67777-407-02Dynashield15 g in 1 PACKETCREAM1510
67777-407-03Dynashield114 g in 1 TUBECREAM11410
67777-407-04Dynashield427.5 g in 1 JARCREAM427.510
67777-407-10Dynashield24 in 1 CASECREAM2410
67777-407-11Dynashield12 in 1 CASECREAM1210
67777-407-12Dynashield144 in 1 BOXCREAM14410
67777-407-12Dynashield5 g in 1 PACKETCREAM510
67777-407-13Dynashield2 in 1 CASECREAM210

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67777-407-03GM - Gram67777-4075e354ef3-ca58-4dfe-b07c-ec80f7f426cf12026-01-08
67777-407-04GM - Gram67777-4073fd1dc00-f15a-4d0f-aae4-b9fe81e8baa812026-04-20
67777-407-10GM - Gram67777-4076d31d5b1-d53b-4cec-b328-a6d5d0546d7a12026-01-08
67777-407-11GM - Gram67777-407949c109c-9a90-45db-8474-0820ca7809b212026-04-20

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-407DYNASHIELD (ZINC OXIDE) CREAM [DYNAREX CORPORATION]9Current NDC, Legacy NDC, 9 package rows20241122_59fd865c-b81d-43ad-8fa0-c37ca0557769.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 15 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Softlips Peppermint SwirlDIMETHICONEThe Mentholatum Company4dbea50e-d82d-c702-e063-6394a90ac6e42026-03-24WarningsExact identifier
application number: M016
Softlips VanillaDIMETHICONEThe Mentholatum Company56551008-a4e0-406f-8403-980d2e6b75a02026-03-24WarningsExact identifier
application number: M016
Selan Plus Zinc OxideSELAN PLUS ZINC OXIDETrividia Manufacturing Solutions, Inc07396c61-1dfd-4be7-bddf-0eb570a184632026-03-24WarningsExact identifier
application number: M016
D-CerinMOISTURIZERDynarex Corporation7ea47a7e-12af-9290-e053-2a91aa0a065f2026-03-24WarningsExact identifier
application number: M016
MG217 Eczema BodyCOLLOIDAL OATMEALWisconsin Pharmacal Company5f0cfd0c-ae87-f411-e053-2a91aa0ac2512026-03-20WarningsExact identifier
application number: M016
Advanced Formula Scar Defense CreamALLANTOINYantai Aien Biotechnology Co., Ltd.4d5c70f9-da41-b535-e063-6294a90a73f22026-03-19WarningsExact identifier
application number: M016
TriplePaste Adult Care Rash TreatmentZINC OXIDEAdvantice Health, LLC2cf0575c-8d3d-1f16-e063-6294a90a629d2026-03-19WarningsExact identifier
application number: M016
multipurposeZINC OXIDE SKIN PROTECTANTAdvantice Health, LLC291563cc-7491-ce41-e063-6394a90ac6c12026-03-19WarningsExact identifier
application number: M016
Triple Diaper RashZINC OXIDEAdvantice Health, LLCd457c58d-8239-41c4-999e-d0ba237e39452026-03-19WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Cranberry PomegranateCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Companyf4464fb2-ba25-16f2-e053-2a95a90a04062026-03-19WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Vanilla CookieCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Companyfea4e5c7-780c-c7f4-e053-6294a90abb392026-03-19WarningsExact identifier
application number: M016
Nicotine PatchesNICOTINE PATCHESZhejiang FTA Shengzuozhi Biotechnology Co., LTD4d46110b-5aa7-5261-e063-6394a90a423a2026-03-18WarningsExact identifier
application number: M016
Advanced Bed Sore Wound HealingALLANTOINYantai Aien Biotechnology Co., Ltd.4d589c18-e597-355a-e063-6394a90a42432026-03-18WarningsExact identifier
application number: M016
MediChoice BarrierDIMETHICONEO&M HALYARD, INC.115c2a2f-d68a-316a-e063-6394a90a27162026-03-17WarningsExact identifier
application number: M016
Nicotine PatchesNICOTINE PATCHESZhejiang FTA Shengzuozhi Biotechnology Co., LTD4d4427b0-25c3-ddf6-e063-6394a90a61532026-03-17WarningsExact identifier
application number: M016
Colloidal OatmealCOLLOIDAL OATMEALWalmart Inc.4a93f77d-41dc-3bab-e063-6394a90a804b2026-03-16Warnings, Adverse reactionsExact identifier
application number: M016
VaselineHEALING JELLYConopco Inc. d/b/a Unileverbd4418b7-c6aa-5e71-e053-2995a90a4cc42026-03-16WarningsExact identifier
application number: M016
Vaseline Intensive Care Deep MoisturePETROLEUMConopco Inc. d/b/a Unilever65cec560-25c7-4076-a33d-a3dd534ff85b2026-03-16WarningsExact identifier
application number: M016
Daily MoisturizingDAILY MOISTRUIZINGWalgreen Co.27452cc7-1ec6-4571-bcd0-0a7103735ee52026-03-13Warnings, Adverse reactionsExact identifier
application number: M016
Tender Moments Delicate Baby Diaper Rash BalmDIMETHICONE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.f09ba452-e1a6-4f45-901f-bb63d4f8e8842026-03-13WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1427410zinc oxide 1.8 % Topical CreamPSN59fd865c-b81d-43ad-8fa0-c37ca055776910
1427410zinc oxide 18 MG/ML Topical CreamSCD59fd865c-b81d-43ad-8fa0-c37ca055776910
1427410zinc oxide 1.8 % Topical CreamSY59fd865c-b81d-43ad-8fa0-c37ca055776910
1427410ZNO 18 MG/ML Topical CreamSY59fd865c-b81d-43ad-8fa0-c37ca055776910

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67777-407-01677770407015 g in 1 PACKET (67777-407-01) 5 g2018-05-230000-00-00NoNoCurrent
67777-407-026777704070215 g in 1 PACKET (67777-407-02) 15 g2018-05-230000-00-00NoNoCurrent
67777-407-0367777040703114 g in 1 TUBE (67777-407-03) 114 g2018-05-230000-00-00NoNoCurrent
67777-407-0467777040704427.5 g in 1 JAR (67777-407-04) 427.5 g2018-05-230000-00-00NoNoCurrent
67777-407-106777704071024 TUBE in 1 CASE (67777-407-10) / 114 g in 1 TUBE (67777-407-03) 24 tube2014-10-010000-00-00NoNoCurrent
67777-407-116777704071112 JAR in 1 CASE (67777-407-11) / 427.5 g in 1 JAR (67777-407-04) 12 jar2014-10-010000-00-00NoNoCurrent
67777-407-1267777040712144 in 1 BOXHistorical
67777-407-13677770407132 BOX in 1 CASE (67777-407-13) / 144 PACKET in 1 BOX (67777-407-12) / 5 g in 1 PACKET2 box2026-03-30NoNoCurrent