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 47 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
A0A0 Rice Ceramide Anti Wrinkle Age Essence Box SetBIFIDA FERMENT LYSATE,ORYZA SATIVA (RICE) EXTRACT,CERAMIDE NP,COLLAGEN,TOCOPHEROL.Guangdong Junhui Biotechnology Co., LTD22736b2d-45a0-49b6-e063-6394a90a7b0b2025-01-08WarningsExact identifier
application number: M016
Body Milk for stretch marksHELIANTHUS ANNUUS (SUNFLOWER) SEED OIL,BUTYROSPERMUM PARKII (SHEA) BUTTER,ARGANIA SPINOSA KERNEL 0IL,TOCOPHEROL,CENTELLA ASIATICA EXTRACT,THEOBROMA CACAO (COCOA) SEED BUTTERGuangzhou Senmai Biotechnology Co.1dcd94dc-214d-de72-e063-6294a90a695f2025-01-08WarningsExact identifier
application number: M016
Stretch Marks creamSESAMUM INDICUM (SESAME) SEED EXTRACT,PRUNUS PERSICA (PEACH) RESIN EXTRACT,STERCULIA URENS GUM,TRIPEPTIDE-1,HEXAPEPTIDE-9,ACETYL TETRAPEPTIDE-9,PALMITOYL PENTAPEPTIDE-4,PALMITOYL TETRAPEPTIDE-7,ACETYL HEXAPEPTIDE-8.Guangzhou Senmai Biotechnology Co.1e827483-259a-d12f-e063-6394a90a78852025-01-08WarningsExact identifier
application number: M016
Body oil for stretch marksHELIANTHUS ANNUUS (SUNFLOWER) SEED 0IL ,TOCOPHEROL,ADANSONIA DIGITATA SEED 0IL,MORINGA OLEIFERA SEED 0IL,THEOBROMA CACAO (COCOA) SEED BUTTER,ECHIUM PLANTAGINEUM SEED OIL,SESAMUM INDICUM (SESAME) SEED 0ILGuangzhou Senmai Biotechnology Co.1daeb2e8-f18c-06c3-e063-6294a90a63852025-01-08WarningsExact identifier
application number: M016
AOA0 Snail Ginseng CreamSNAIL SECRETION FILTRATE,PANAX GINSENG ROOT EXTRACT,COLLAGEN,TOCOPHEROL,ASCORBIC ACID.Guangdong Junhui Biotechnology Co., LTD22873a99-1032-f4ec-e063-6394a90a64322025-01-08WarningsExact identifier
application number: M016
Massage cream for stretch marksHELIANTHUS ANNUUS (SUNFLOWER) SEED 0IL,BUTYROSPERMUM PARKII (SHEA) BUTER,ARGANIA SPINOSA KERNEL 0IL,TOCOPHEROL,CENTELLA ASIATICA EXTRACT,CERAMIDE NP,SOLUBLE COLLAGEN,HYDROLYZED ELASTIN,PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OILGuangzhou Senmai Biotechnology Co.1dce7cf1-1fb8-e14e-e063-6394a90ae34a2025-01-08WarningsExact identifier
application number: M016
AOAO Retinol Anti-aging Box SetCOLLAGEN,BUTYROSPERMUM PARKII (SHEA) BUTTER EXTRACT,HYALURONIC ACID,CAFFEINE,SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL,RETINOL.Guangdong Junhui Biotechnology Co., LTD24fdc31b-5291-a649-e063-6394a90a9c652025-01-08WarningsExact identifier
application number: M016
Sulfur anti-mite shower gelSODIUM LAURETH SULFAT,DECYL GLUCOSIDE,PALM KERNELAMIDE DEA,COCAMIDOPROPYL BETAINE,LONICERA JAPONICA(HONEYSUCKLE) FLOWER EXTRACT,COLLOIDAL SULFUR.Guangdong Junhui Biotechnology Co., Ltd251ee057-1adf-bc97-e063-6394a90acdd32025-01-08WarningsExact identifier
application number: M016
TURMERICFaceCreamNIACINAMIDEShengnan (Guangzhou) Cosmetics Co., LTD2b0652be-a216-d66b-e063-6394a90a0b282025-01-06WarningsExact identifier
application number: M016
Menthol and Zinc OxideMENTHOL AND ZINC OXIDEGERI-GENTLE CORPORATIONe673d8bd-2573-9f04-e053-2995a90a172a2025-01-06WarningsExact identifier
application number: M016
ClearSoothingCreamHYALURONIC ACIDShengnan (Guangzhou) Cosmetics Co., LTD2ac88f9a-a41b-1978-e063-6394a90a24212025-01-03WarningsExact identifier
application number: M016
MILKBODyLotionUREAShengnan (Guangzhou) Cosmetics Co., LTD2ac99028-a811-9332-e063-6294a90aee5c2025-01-03WarningsExact identifier
application number: M016
Royal Jelly Scar BalmDIMETHICONEDistribuidora Comercial Jafra, S.A. de C.V.27be84c1-0227-41ca-beb6-3855eff77e412025-01-02WarningsExact identifier
application number: M016
Vitamin A and DPETROLATUMTrifecta Pharmaceuticals USA LLCf1ea9640-4a6d-1c76-e053-2a95a90ad3b12024-12-31WarningsExact identifier
application number: M016
Badger DiaperZINC OXIDEW.S. Badger Company, Inc.674542b2-33fb-4664-857d-4ff1d7f768a02024-12-31WarningsExact identifier
application number: M016
A and D Diaper Rash and Skin ProtectantLANOLIN AND PETROLATUMNatureplex LLCfcaf27c9-3634-4fb7-a311-2e093f0552782024-12-31WarningsExact identifier
application number: M016
ELIZABETH ARDEN EIGHT HR PROTECTANT CLEARLIP PROTECTANTREVLON CONSUMER PRODUCTS CORPf3a6fe29-7af7-bfb1-e053-2a95a90a01012024-12-30WarningsExact identifier
application number: M016
SkinCeuticals Advanced Scar Control Skin ProtectantALLANTOINL'Oreal USA Products Inc83f4bfbb-47d8-4fe9-ba33-85142ec6221c2024-12-28WarningsExact identifier
application number: M016
Personal Cleansing with DimethiconeDIMETHICONECardinal Health 200, Inc3f9a1a90-ab12-4911-b8c2-df200b0dde5b2024-12-27WarningsExact identifier
application number: M016
NUDESCREEN DAILY MINERAL VEIL SPF 30 - TINT NUDEZINC OXIDEBentley Laboratories, LLCa35ae585-f899-4c7e-8cd2-c0b2fe6a20782024-12-27WarningsExact 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