FDA.reportPublic FDA data

Zinc Oxide

Product NDC
68001-532
11-digit product format
680010532
Labeler code
68001
Product ID
68001-532_097e3a92-864a-aef4-e063-6294a90abcf3
Type
HUMAN OTC DRUG
Nonproprietary name
Skin Protectant
Dosage form
OINTMENT
Route
TOPICAL
Labeler
BluePoint Laboratories
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-03-24
Substance
ZINC OXIDE
Active strength
20 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
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
Zinc Oxide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE20 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
198911Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d9b752e6-655a-19a6-e053-2995a90a9a37Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68001-532-45Zinc Oxide1 in 1 CARTONOINTMENT13
68001-532-45Zinc Oxide30 g in 1 TUBEOINTMENT303
68001-532-46Zinc Oxide1 in 1 CARTONOINTMENT13
68001-532-46Zinc Oxide60 g in 1 TUBEOINTMENT603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-532-45GM - Gram68001-532669ed332-a5a8-4bca-9d28-81f40c7bbd6312022-08-04
68001-532-46GM - Gram68001-532217d5eb8-6481-46d3-9782-36cbb0063f5412022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-532ZINC OXIDE (SKIN PROTECTANT) OINTMENT [BLUEPOINT LABORATORIES]3Current NDC, Legacy NDC, 4 package rows20231118_d9b752e6-655a-19a6-e053-2995a90a9a37.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
198911zinc oxide 20 % Topical OintmentPSNd9b752e6-655a-19a6-e053-2995a90a9a373
198911zinc oxide 0.2 MG/MG Topical OintmentSCDd9b752e6-655a-19a6-e053-2995a90a9a373
198911zinc oxide 20 % Topical OintmentSYd9b752e6-655a-19a6-e053-2995a90a9a373
198911zinc oxide 200 MG per GM Topical OintmentSYd9b752e6-655a-19a6-e053-2995a90a9a373
198911ZNO 0.2 MG/MG Topical OintmentSYd9b752e6-655a-19a6-e053-2995a90a9a373

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-532-45680010532451 TUBE in 1 CARTON (68001-532-45) / 30 g in 1 TUBE1 tube2022-03-240000-00-00NoNoCurrent
68001-532-46680010532461 TUBE in 1 CARTON (68001-532-46) / 60 g in 1 TUBE1 tube2022-03-240000-00-00NoNoCurrent