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 67 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
calahistCALAMINE AND PRAMOXINE HYDROCHLORIDEWALGREEN COMPANYfed45e06-cc53-fbc5-e053-6294a90a1b192023-10-27WarningsExact identifier
application number: M016
calahist clearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEWALGREEN COMPANYfed469c2-fe13-6726-e053-6394a90a5f512023-10-27WarningsExact identifier
application number: M016
Dr. Sayman SalveSALVESheffield Pharmaceuticals LLC18bdcd0c-9c81-47e1-ae24-2239ff8fd0662023-10-24WarningsExact identifier
application number: M016
Theriac Advanced HealingLANOLINSheffield Pharmaceuticals LLCc780cd27-dc9e-45f3-97f0-e59b1b6b955a2023-10-24WarningsExact identifier
application number: M016
Babo Botanicals Sensitive Baby Fragrance Free Diaper RashZINC OXIDEBabo Botanicals, Inc.d66e369e-9b19-b084-e053-2995a90aa2592023-10-23WarningsExact identifier
application number: M016
Babo Botanicals Sensitive Baby HealingCOLLOIDAL OATMEALBabo Botanicals, Inc.08659a5c-2d10-2f98-e063-6394a90a77602023-10-23WarningsExact identifier
application number: M016
White Rose Petroleum JellyPETROLATUMJ. Strickland & Co.1aeb090d-c103-4c2e-accc-d9d248315db92023-10-21WarningsExact identifier
application number: M016
Tricalm HydrogelALUMINUM ACETATEMODULAR THERMAL TECHNOLOGIES LLC DBA LIFE WEAR TECHNOLOGIES082c6441-be47-4466-e063-6394a90ad5002023-10-20WarningsExact identifier
application number: M016
EmpowerWHITE PETROLATUM, ZINC OXIDEBemis Manufacturing Company Inc08006b60-966b-155b-e063-6294a90a206a2023-10-18WarningsExact identifier
application number: M016
ANUBISMEDHA HYALURONICANUBIS COSMETICS SLeac771e2-4c1b-3808-e053-2995a90ac5fc2023-09-05WarningsExact identifier
application number: M016
AnubisMedSODIUM BICARBONATE, ALOE BARBADENSIS LEAF JUICE, IMIDAZOLIDINYL UREAANUBIS COSMETICS SLebf4b3ab-34e1-185a-e053-2a95a90ace3a2023-09-05WarningsExact identifier
application number: M016
Anubis BarcelonaGLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICEANUBIS COSMETICS SLeb651769-4d98-2b3b-e053-2a95a90a36b02023-09-01WarningsExact identifier
application number: M016
Anubis BarcelonaDMAEANUBIS COSMETICS SLf22b212d-d21d-5984-e053-2995a90a683e2023-09-01WarningsExact identifier
application number: M016
Anubis BarcelonaDMAE, ZIRHAFIRMANUBIS COSMETICS SLf2274f8c-08aa-eb02-e053-2a95a90a39982023-09-01WarningsExact identifier
application number: M016
Anubis Barcelona Vital LineHYDROLYZED ELASTIN, HYDROLYSED COLLAGEN, COCOGLYCERIDESANUBIS COSMETICS SLebe024f7-7c45-ad60-e053-2995a90a45d62023-09-01WarningsExact identifier
application number: M016
Anubis BarcelonaPROTEOGLYCAN, GLYCERIN, BUTYLENE GLYCOLANUBIS COSMETICS SLebdddcec-f5da-51fe-e053-2995a90a61672023-09-01WarningsExact identifier
application number: M016
Anubis BarcelonaPROPANEDIOL, GLYCERIN, MAGNESIUM ASCORBYL PHOSPHATEANUBIS COSMETICS SLeb53cba1-0509-43bc-e053-2995a90a5e092023-09-01WarningsExact identifier
application number: M016
Anubis Barcelona Spa LineORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACIDANUBIS COSMETICS SLeb01a962-ab38-18ec-e053-2995a90acdeb2023-09-01WarningsExact identifier
application number: M016
Anubis BarcelonaFERULIC ACID, VITAMIN C, DMAEANUBIS COSMETICS SLeaf0770c-795d-0232-e053-2a95a90ae0b52023-09-01WarningsExact identifier
application number: M016
Anubis Barcelona Total HydratingBETAINE, GLYCERIN, POLYSORBATE 20ANUBIS COSMETICS SLeaefe3b9-9064-18b1-e053-2a95a90a57652023-09-01WarningsExact 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