Vitamin A and D

Product NDC
55319-603
11-digit product format
553190603
Labeler code
55319
Product ID
55319-603_1d840d5b-abd5-c809-e063-6394a90a02ba
Type
HUMAN OTC DRUG
Nonproprietary name
Vitamin A and D
Dosage form
OINTMENT
Route
TOPICAL
Labeler
MIDWOOD BRANDS, LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-12
Substance
PETROLATUM; LANOLIN
Active strength
53.4; 15.5 g/100g; 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
Vitamin A and D
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM53.4 g/100g
LANOLIN15.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4T6H12BN9UInternal UNII lookup
7EV65EAW6HInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
664981Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1d0ebe9a-cbc5-1765-e063-6294a90aa476Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-603-01Vitamin A and D113 g in 1 TUBEOINTMENT1132

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-603VITAMIN A AND D OINTMENT [MIDWOOD BRANDS, LLC]2Current NDC, 1 package rows20240723_1d0ebe9a-cbc5-1765-e063-6294a90aa476.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 55 of 68 · 1,343 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aveeno Baby Daily Care SetDIMETHICONEKenvue Brands LLC62025bfa-245e-4369-9949-d31ea455ad312024-11-05WarningsExact identifier
application number: M016
Aveeno Baby Continuous Protection Sensitive Skin Mineral Sunscreen Broad Spectrum SPF 50ZINC OXIDEKenvue Brands LLCf2fd12cf-45c0-163f-e053-2a95a90ad4592024-11-05WarningsExact identifier
application number: M016
Aveeno Baby Daily Care SetDIMETHICONEKenvue Brands LLC3d3da49e-dba6-4c6b-9278-5c8692e29f142024-11-05WarningsExact identifier
application number: M016
Aveeno Eczema Therapy Itch Relief BalmOATMEALKenvue Brands LLCbab3b767-864c-4c9f-b812-4fbd2bf2ca772024-11-05WarningsExact identifier
application number: M016
Aveeno Skin Relief Moisturizing Fragrance FreeDIMETHICONEKenvue Brands LLC1bad1069-b169-4bc9-8eb8-5123d57f74e52024-11-05WarningsExact identifier
application number: M016
Aveeno Skin Relief Moisturizing Fragrance FreeDIMETHICONEKenvue Brands LLCe0d9b055-be7a-8bba-e053-2995a90ab9e32024-11-05WarningsExact identifier
application number: M016
Aveeno Eczema Therapy daily moisturizingOATMEALKenvue Brands LLCdcbdb2ce-3877-41ea-9978-986e17a7c8772024-11-05WarningsExact identifier
application number: M016
Aveeno Baby Daily MoistureDIMETHICONEKenvue Brands LLC3879110f-ba83-446b-b580-f8eaa859789d2024-11-05WarningsExact identifier
application number: M016
Aveeno Daily MoisturizingDIMETHICONEKenvue Brands LLC70593b0c-c41b-4294-9bfa-42003ba1e3e42024-11-05WarningsExact identifier
application number: M016
Aveeno Baby Calming ComfortDIMETHICONEKenvue Brands LLC029fbae2-06ad-4fe9-b542-834686c5cb972024-11-05WarningsExact identifier
application number: M016
Aveeno Skin Relief OvernightDIMETHICONEKenvue Brands LLCe7da6c9c-d6b0-4dc5-bfa4-68345f9c2d3c2024-11-05WarningsExact identifier
application number: M016
Quality Choice Diaper RashZINC OXIDEChain Drug Marketing Association Inc.262e7eac-4b44-f224-e063-6394a90a4f592024-11-05WarningsExact identifier
application number: M016
Zinc Oxide 20%ZINC OXIDEChain Drug Marketing Association Inc.262f8cab-c7b8-b07e-e063-6294a90a12892024-11-05WarningsExact identifier
application number: M016
ECZEMAOATMEALORGANIC & SUSTAINABLE BEAUTY926706b5-0a08-4604-b5ad-3b3ddfd7f02d2024-11-05WarningsExact identifier
application number: M016
Walgreens Eczema Relief Body Skin ProtectantOATMEALWalgreen Companyb2eebc2f-addd-4822-b224-04bd5f4506532024-11-05WarningsExact identifier
application number: M016
ECZEMAOATMEALORGANIC & SUSTAINABLE BEAUTY81eb3df4-5beb-45aa-82ca-e8b4b37e45f42024-11-05Warnings, Adverse reactionsExact identifier
application number: M016
Aveeno Baby Calming ComfortDIMETHICONEKenvue Brands LLC567b1481-b783-45f9-af38-5630c9edf0442024-11-01WarningsExact identifier
application number: M016
ZO Skin Health Astringent SolutionALUMINUM ACETATEZO Skin Health, Inc.cb801d7e-52ad-6c16-e053-2a95a90a7a1f2024-10-31WarningsExact identifier
application number: M016
ZINC OXIDE PHARMAZINC OXIDEALLIED TRADE LINK LLC1b580bf6-f217-5c0f-e063-6294a90a012e2024-10-29WarningsExact identifier
application number: M016
Dove DermaSeries Eczema Relief Soothing BodyCOLLOIDAL OATMEALConopco, Inc. d/b/a/ Unilever59f737f6-dd3f-4b63-b13e-2345cb9a951a2024-10-24WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
664981lanolin 15.5 % / petrolatum 53.4 % Topical OintmentPSN1d0ebe9a-cbc5-1765-e063-6294a90aa4762
664981lanolin 0.155 MG/MG / petrolatum 0.534 MG/MG Topical OintmentSCD1d0ebe9a-cbc5-1765-e063-6294a90aa4762
664981lanolin 15.5 % / petrolatum 53.4 % Topical OintmentSY1d0ebe9a-cbc5-1765-e063-6294a90aa4762
664981lanolin 15.5 GM per 100 GM / petrolatum 53.4 GM per 100 GM Topical OintmentSY1d0ebe9a-cbc5-1765-e063-6294a90aa4762

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55319-603-0155319060301113 g in 1 TUBE (55319-603-01) 113 g2024-07-12NoNoCurrent