FDA.reportPublic FDA data

AD PREVENT Original

Product NDC
65197-401
11-digit product format
651970401
Labeler code
65197
Product ID
65197-401_d45682ea-98dd-4a57-8f58-c6ccadc01dc9
Type
HUMAN OTC DRUG
Nonproprietary name
AD PREVENT Original
Dosage form
OINTMENT
Route
TOPICAL
Labeler
WellSpring Pharmaceutical Corporation
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-02
Substance
LANOLIN; PETROLATUM
Active strength
15.5; 53.4 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
AD PREVENT Original
Listing expiration
2027-12-31

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
cf73246e-81c1-42e9-a107-dc6c99cf7d01Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65197-401-00AD PREVENT Original454 g in 1 JAROINTMENT4546
65197-401-01AD PREVENT Original113 g in 1 TUBEOINTMENT1136
65197-401-01AD PREVENT Original1 in 1 BOXOINTMENT16
65197-401-12AD PREVENT Original42.5 g in 1 TUBEOINTMENT42.56
65197-401-12AD PREVENT Original1 in 1 BOXOINTMENT16
65197-401-99AD PREVENT Original567 g in 1 CARTONOINTMENT5676

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65197-401-01GM - Gram65197-4017170bc38-f941-4d11-a7a7-66e801dac98f12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65197-401AD PREVENT ORIGINAL OINTMENT [WELLSPRING PHARMACEUTICAL CORPORATION]5Current NDC, 6 package rows20250110_cf73246e-81c1-42e9-a107-dc6c99cf7d01.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 58 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
insect bite relief 01MENTHOLCosmuses Cosmetics (Ningbo) Co., Ltd.006e457d-bfcd-791a-e063-6294a90a8d662024-09-23WarningsExact identifier
application number: M016
daburZINC OXIDEDabur India Limited22cd1e7a-5448-b3f6-e063-6394a90a880d2024-09-23WarningsExact identifier
application number: M016
DABUR Vitamin A and DWHITE PETROLATUMDabur India Limited22cd44ef-4b02-604d-e063-6394a90a7a0a2024-09-23WarningsExact identifier
application number: M016
DABUR ZINC OXIDE 3.8%ZINC OXIDEDabur India Limited2290bbe2-8a88-b94e-e063-6294a90a7e382024-09-20WarningsExact identifier
application number: M016
Aveeno Baby Daily MoistureDIMETHICONEKenvue Brands LLCb34c8e71-7fad-484c-b387-3c424f50b7432024-09-19WarningsExact identifier
application number: M016
Evereden Intensive Eczema BalmCOLLOIDAL OATMEALEden Brands Inc.2243d4ca-5ca4-54d0-e063-6394a90a39402024-09-16WarningsExact identifier
application number: M016
Whipped GelCOLLOIDAL OATMEALOCEAN OLIVE LLC222b381c-665e-177d-e063-6394a90a33062024-09-15WarningsExact identifier
application number: M016
BioBarrier Renewal CreamALLANTOINbluemercury1ee15f84-0561-3cd2-e063-6394a90ab68e2024-09-15WarningsExact identifier
application number: M016
CalamineCALAMINE AND ZINC OXIDEStrategic Sourcing Services, LLC22173332-9d09-768c-e063-6394a90a94e12024-09-14WarningsExact identifier
application number: M016
Diaper Rash Cream 5.6ozZINC OXIDEChina Ningbo Shangge Cosmetics Technology Corp.21a7c4ce-1360-931c-e063-6294a90aa66d2024-09-11WarningsExact identifier
application number: M016
Healing Cream 3ozPETROLATUMChina Ningbo Shangge Cosmetics Technology Corp.21bdbb13-cc64-b5d7-e063-6294a90ae3fd2024-09-11WarningsExact identifier
application number: M016
Healing Cream15ozPETROLATUMRejoice International Corp.21e4026c-d3da-e4f7-e063-6394a90aabed2024-09-11WarningsExact identifier
application number: M016
Baby Balm Stick 0.65ozPETROLATUM OINTMENTChina Ningbo Shangge Cosmetics Technology Corp.21c0b614-ea19-e98d-e063-6294a90ac44e2024-09-10WarningsExact identifier
application number: M016
Aveeno Skin Relief Moisturizing Fragrance FreeDIMETHICONEKenvue Brands LLC65476a2a-8cd4-4477-ac27-9a06f41e47112024-09-09WarningsExact identifier
application number: M016
Diaper Rash Cream 15ozZINC OXIDERejoice International Corp.213213ab-f935-a62e-e063-6394a90af96b2024-09-03WarningsExact identifier
application number: M016
Diaper Rash Cream 5.6ozZINC OXIDERejoice International Corp.2133876b-eaf0-f988-e063-6394a90aae4d2024-09-03WarningsExact identifier
application number: M016
Baby Balm Stick 0.65ozPETROLATUMRejoice International Corp.20cf3bb8-4ab8-2980-e063-6294a90ad6312024-08-29WarningsExact identifier
application number: M016
SUDOCREM SKIN PROTECTANTZINC OXIDELEDA INNOVATIONS USA, INC.20d2cf0b-d237-fd78-e063-6394a90a8d032024-08-29WarningsExact identifier
application number: M016
Healing Cream 3ozPETROLATUMRejoice International Corp.20c9b964-c9af-d63a-e063-6294a90ab9792024-08-28WarningsExact identifier
application number: M016
Babyganics Soothing ItchOATMEALKAS Direct, LLC5c2806fb-5af4-4532-b31a-be77bb23b2772024-08-28WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
664981lanolin 15.5 % / petrolatum 53.4 % Topical OintmentPSNcf73246e-81c1-42e9-a107-dc6c99cf7d016
664981lanolin 0.155 MG/MG / petrolatum 0.534 MG/MG Topical OintmentSCDcf73246e-81c1-42e9-a107-dc6c99cf7d016
664981lanolin 15.5 % / petrolatum 53.4 % Topical OintmentSYcf73246e-81c1-42e9-a107-dc6c99cf7d016
664981lanolin 15.5 GM per 100 GM / petrolatum 53.4 GM per 100 GM Topical OintmentSYcf73246e-81c1-42e9-a107-dc6c99cf7d016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65197-401-0065197040100454 g in 1 JAR (65197-401-00) 454 g2023-11-01NoNoCurrent
65197-401-01651970401011 TUBE in 1 BOX (65197-401-01) / 113 g in 1 TUBE1 tube2023-10-02NoNoCurrent
65197-401-12651970401121 TUBE in 1 BOX (65197-401-12) / 42.5 g in 1 TUBE1 tube2023-10-02NoNoCurrent
65197-401-9965197040199567 g in 1 CARTON (65197-401-99) 567 g2025-07-01NoNoCurrent