FDA.reportPublic FDA data

Vitamin A and D

Product NDC
69396-018
11-digit product format
693960018
Labeler code
69396
Product ID
69396-018_29b3cf7a-794b-6a29-e063-6294a90ac3d7
Type
HUMAN OTC DRUG
Nonproprietary name
Lanolin, Petrolatum
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Trifecta Pharmaceuticals USA LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-01-05
Substance
LANOLIN; PETROLATUM
Active strength
15.5; 53.4 g/100g; 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
Vitamin A and D
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7EV65EAW6HInternal UNII lookup
4T6H12BN9UInternal 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
455a16fd-9ce5-6bef-e054-00144ff88e88Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-018-05Vitamin A and D15 g in 1 TUBEOINTMENT156
69396-018-05Vitamin A and D1 in 1 BOXOINTMENT16
69396-018-40Vitamin A and D113 g in 1 TUBEOINTMENT1136
69396-018-40Vitamin A and D1 in 1 BOXOINTMENT16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69396-018-05GM - Gram69396-0182fe02ce9-7c4c-4994-815a-fee3f7ec993e12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-018VITAMIN A AND D (LANOLIN, PETROLATUM) OINTMENT [TRIFECTA PHARMACEUTICALS USA LLC]6Current NDC, Legacy NDC, 4 package rows20241222_455a16fd-9ce5-6bef-e054-00144ff88e88.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 6 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mederma PMDIMETHICONEPMI Branded Pharmaceuticals, Inc.26737285-f6ae-47eb-9019-33f1cfce30292026-07-15WarningsExact identifier
application number: M016
MEDERMA STRETCH MARKS THERAPYDIMETHICONEL. Perrigo Companye9366775-e85b-4403-a2c5-12d9fb3cc3fa2026-07-15WarningsExact identifier
application number: M016
Remedy Barrier Cream Cloths Fragrance FreeDIMETHICONEMedline Industries, LP00e0cd4a-6049-408a-ab3f-9edf97e6438a2026-07-14WarningsExact identifier
application number: M016
Cruex Petroleum JellyWHITE PETROLATUMMKJ BRANDS LLC3e61191a-e0fa-3477-e063-6294a90a7d192026-07-14WarningsExact identifier
application number: M016
Cruex Petroleum JellyWHITE PETROLATUMMKJ BRANDS LLC459a90b8-7d52-ef70-e063-6394a90ac1d02026-07-14WarningsExact identifier
application number: M016
Mederma for KidsALLANTOINL. Perrigo Companyed4ff435-9819-46d3-9375-914712943f772026-07-14WarningsExact identifier
application number: M016
Baby 3-in-1 Diaper RashBABY 3-IN-1 DIAPER RASHWalgreens5632dde2-f59d-3a45-e063-6394a90a1a242026-07-09WarningsExact identifier
application number: M016
Drs. DIAPER RASH MAXIMUM STRENGTHZINC OXIDEOL PHARMA TECH, LLC Drs PHARMACY161ba174-1b13-83cd-e063-6394a90af19c2026-07-09WarningsExact identifier
application number: M016
Drs. Hydrocortisone Aloe VeraHYDROCORTISONEOL PHARMA TECH,LLC0df06415-5d32-7ef8-e063-6294a90a6e5a2026-07-09WarningsExact identifier
application number: M016
SOHEJU Nail Repairs PatchesGLYCERINShantou Ximonth Biotechnology Co., Ltd.560089ff-3361-90b7-e063-6294a90ada422026-07-09WarningsExact identifier
application number: M016
Bee Venom Psoriasis Wart Caring CreamGLYCERINShantou Ximonth Biotechnology Co., Ltd.563a423c-e9dd-1cab-e063-6294a90a8c6a2026-07-09WarningsExact identifier
application number: M016
Skin Protectant with LanolinLANOLINMcKesson Medical-Surgical Inc.46df52c8-0cbf-213e-e054-00144ff88e882026-07-08WarningsExact identifier
application number: M016
Skin Protectant with LanolinLANOLINMcKesson5abe1b34-f71b-2a90-e053-2991aa0aded62026-07-08WarningsExact identifier
application number: M016
Walgreens Baby Healing BalmPETROLATUMWalgreens561c1e1e-e896-d6e9-e063-6394a90ac0e72026-07-08WarningsExact identifier
application number: M016
AD Overnight HealingAD OVERNIGHT HEALINGWellSpring Pharmaceutical Corporation57c29db6-da0c-4b28-86c0-6ac1b71224282026-07-07WarningsExact identifier
application number: M016
EczeNourish Eczema and Psoriasis Soothing OatCOLLOIDAL OATMEALVanguard Soap, LLC55f7137f-c5a5-f2ce-e063-6394a90a52802026-07-07WarningsExact identifier
application number: M016
FDS intimate Whole Body Medicated ChafingFDS INTIMATE WHOLE BODY MEDICATED CHAFINGWellSpring Pharmaceutical Corporationef01fcd8-2fe4-4076-a4d4-e730a5c2b31c2026-07-07WarningsExact identifier
application number: M016
AD First Aid MultipurposeAD FIRST AID MULTIPURPOSEWellSpring Pharmaceutical Corporation999989d8-21c2-4380-b4c1-e5421189f6ed2026-07-07WarningsExact identifier
application number: M016
AD Anti-ChafingAD ANTI-CHAFINGWellSpring Pharmaceutical Corporationd272ab4a-eb18-4f64-b925-fccf637dbb022026-07-06WarningsExact identifier
application number: M016
ECZEMA NOURISH MEDICATED CLEANSING BARCOLLOIDAL OATMEAL SKIN PROTECTANTVanguard Soap, LLC55f865dc-d88e-fe2f-e063-6294a90aa7d32026-07-06WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
664981lanolin 15.5 % / petrolatum 53.4 % Topical OintmentPSN455a16fd-9ce5-6bef-e054-00144ff88e886
664981lanolin 0.155 MG/MG / petrolatum 0.534 MG/MG Topical OintmentSCD455a16fd-9ce5-6bef-e054-00144ff88e886
664981lanolin 15.5 % / petrolatum 53.4 % Topical OintmentSY455a16fd-9ce5-6bef-e054-00144ff88e886
664981lanolin 15.5 GM per 100 GM / petrolatum 53.4 GM per 100 GM Topical OintmentSY455a16fd-9ce5-6bef-e054-00144ff88e886

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69396-018-05693960018051 TUBE in 1 BOX (69396-018-05) / 15 g in 1 TUBE1 tube2017-01-050000-00-00NoNoCurrent
69396-018-40693960018401 TUBE in 1 BOX (69396-018-40) / 113 g in 1 TUBE1 tube2019-12-19NoNoCurrent