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 48 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NUDESCREEN DAILY MINERAL VEIL SPF 30 - TINT TANZINC OXIDEBentley Laboratories, LLC7920708a-6fa7-4bc8-94ba-096e77d9d7e12024-12-27WarningsExact identifier
application number: M016
AD Medicated RashAD MEDICATED RASHWellSpring Pharmaceutical Corporationaac345bf-ea66-4f5b-a497-c24ea72f93ea2024-12-27WarningsExact identifier
application number: M016
ZO Skin Health Post Procedure Recovery SystemALUMINUM ACETATEZO Skin Health, Inc.3b977415-2bf4-43a9-bb48-1eb023ca4f532024-12-27WarningsExact identifier
application number: M016
terrasil Scar RecoveryALLANTOINAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions2a2f91ff-a447-9d2a-e063-6394a90a84f82024-12-26WarningsExact identifier
application number: M016
WITCH HAZELWITCH HAZELCHAIN DRUG MARKETING ASSOCIATION INCbdccee3f-0ad8-4264-a65f-ae86aed6bf032024-12-26WarningsExact identifier
application number: M016
All Over Lavender RosemaryCOLLOIDAL OAT OINTMENTTubby Todd29f46671-7467-95c9-e063-6294a90a13542024-12-23WarningsExact identifier
application number: M016
Sweet Cheeks Diaper SprayerZINC OXIDE DIAPER PASTE SPRAYTubby Todd29f4aa3c-d10e-52a5-e063-6294a90acc4b2024-12-23WarningsExact identifier
application number: M016
calamineCALAMINE AND ZINC OXIDEWALGREEN COMPANYfed3026b-3473-26fe-e053-6294a90a8aa22024-12-23WarningsExact identifier
application number: M016
CUREFINIPETROLATUM, COD LIVER OILMiramar Cosmetics, Inc DBA Miramar Labfc9211db-71aa-44d8-a00b-65f1482d39812024-12-23WarningsExact identifier
application number: M016
CUREFINIPETROLATUMMiramar Cosmetics, Inc DBA Miramar Lab6a2610ca-ca80-451f-8fed-b982443a10b92024-12-23WarningsExact identifier
application number: M016
Vitamin A and DLANOLIN, PETROLATUMTrifecta Pharmaceuticals USA LLC453dffec-de9d-0eac-e054-00144ff8d46c2024-12-20WarningsExact identifier
application number: M016
Vitamin A and DLANOLIN, PETROLATUMTrifecta Pharmaceuticals USA LLC455a16fd-9ce5-6bef-e054-00144ff88e882024-12-20WarningsExact identifier
application number: M016
White PetrolatumPETROLATUMTrifecta Pharmaceuticals USA LLCf1eb0ec2-98e7-13a2-e053-2a95a90a29382024-12-20WarningsExact identifier
application number: M016
Zinc Oxide 20%ZINC OXIDEPharmacy Value Alliance, LLC38018e3f-3778-01d1-e054-00144ff8d46c2024-12-20WarningsExact identifier
application number: M016
DiaperRashOintmentZINC OXIDEPharmacy Value Alliance, LLC3aace6d8-d24c-00e1-e054-00144ff8d46c2024-12-20WarningsExact identifier
application number: M016
Medicated Body PowderMENTHOLNew Pride Corpf0f0e332-cb93-42a7-e053-2995a90ac4ae2024-12-19WarningsExact identifier
application number: M016
Health Smart Medicated BodyMENTHOL AND ZINC OXIDEInternational Wholesale Inc dba Home Smart Products044870e2-ebac-a095-e063-6294a90a27512024-12-19WarningsExact identifier
application number: M016
White Rain Original PetroleumWHITE PETROLEUMINTERNATIONAL WHOLESALE INC.d6ebe00c-b692-5171-e053-2a95a90a976c2024-12-19WarningsExact identifier
application number: M016
Health Smart Original PetroleumWHITE PETROLEUMHome Smart Productsaedf746f-4c49-421d-a666-1ba02e8fb17d2024-12-19WarningsExact identifier
application number: M016
white rain Cocoa Butter Petroleum JellyWHITE PETROLATUMINTERNATIONAL WHOLESALE INC.d7068e2b-c3b2-d16d-e053-2a95a90a6dd22024-12-19WarningsExact 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