FDA.reportPublic FDA data

AquaSoothe

Product NDC
67777-555
11-digit product format
677770555
Labeler code
67777
Product ID
67777-555_45878c3c-d05e-984c-e063-6294a90a4661
Type
HUMAN OTC DRUG
Nonproprietary name
AquaSoothe
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Dynarex Corporation
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-16
Substance
PETROLATUM
Active strength
41 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
AquaSoothe
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM41 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
725145Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
45878c3c-d05d-984c-e063-6294a90a4661Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-555-01AquaSoothe106 g in 1 TUBEOINTMENT1061
67777-555-02AquaSoothe24 in 1 CASEOINTMENT241
67777-555-03AquaSoothe396.9 g in 1 JAROINTMENT396.91
67777-555-04AquaSoothe12 in 1 CASEOINTMENT121
67777-555-05AquaSoothe0.9 g in 1 PACKETOINTMENT0.91
67777-555-05AquaSoothe144 in 1 BOXOINTMENT1441
67777-555-06AquaSoothe12 in 1 CASEOINTMENT121

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67777-555-01GM - Gram67777-5557d95612f-11fb-4d15-b3a5-0bcfb61cf42212026-05-22
67777-555-02GM - Gram67777-5555367718f-17a0-4c08-a67f-b4cadb13e4b312026-05-22
67777-555-03GM - Gram67777-555d9b396fa-137d-4055-9b67-4a5d73d0962212026-05-22
67777-555-04GM - Gram67777-555f2d93837-49d4-4dee-b470-d50af372b32312026-05-22

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 49 of 68 · 1,343 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Health Smart Baby PetroleumWHITE PETROLEUMHome Smart Productsedd9d018-c2c9-4a9a-b727-0a92cd463c022024-12-18WarningsExact identifier
application number: M016
Health Smart Cocoa Butter PetroleumWHITE PETROLEUMHome Smart Productsa65c8267-d34f-4542-a7ca-5180e860a03d2024-12-18WarningsExact identifier
application number: M016
Princess PetroleumWHITE PETROLATUMUltra Distributors Inc.6d9c92bf-9263-40a4-acac-5c3f0b08c69d2024-12-18WarningsExact identifier
application number: M016
Meijer Petroleum JellyWHITE PETROLATUMMeijer Distribution, Incb299cf2a-2c6a-68f4-e053-2995a90a5bd72024-12-18WarningsExact identifier
application number: M016
Foster and Thrive CaldyphenCALAMINE AND PRAMOXINE HYDROCHLORIDEStrategic Sourcing Services, LLC29945734-4ea6-b702-e063-6294a90ae6f22024-12-18WarningsExact identifier
application number: M016
Foster and Thrive Caldyphen ClearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEStrategic Sourcing Services, LLC29946912-9794-8a8e-e063-6394a90a279e2024-12-18WarningsExact identifier
application number: M016
Caring Mills Petroleum JellyWHITE PETROLATUMVeridian Healthcarefbbfa780-0e2b-1874-e053-6394a90a5eeb2024-12-18WarningsExact identifier
application number: M016
Serawise Eczema RescueOATMEALDrAnaMaria.com LLCe805866a-2349-4b86-bc83-a7c859cb94032024-12-18WarningsExact identifier
application number: M016
TheraCare Petroleum JellyWHITE PETROLATUMVeridian Healthcared6fad49b-8a49-7f7c-e053-2a95a90ae6382024-12-18WarningsExact identifier
application number: M016
Shea Butter Petroleum JellyPETROLATUM JELLYWalgreense35d913e-2195-4e3d-ae38-f010317140fd2024-12-17WarningsExact identifier
application number: M016
Jell Pharmaceuticals Vitamin A DPETROLATUMJell Pharmaceuticals Pvt. Ltd.6ab8ba54-3679-4fd0-a876-cb89aace96ca2024-12-17WarningsExact identifier
application number: M016
Shea Butter Petroleum JellyPETROLATUM JELLYJell Pharmaceuticals Pvt. Ltd.cd848f33-e863-d3af-e053-2a95a90a45b12024-12-17WarningsExact identifier
application number: M016
Softlips Cherry, Raspberry, VanillaDIMETHICONEThe Mentholatum Companyb7b2f64e-27b4-4c71-95cf-78b37540f9752024-12-17WarningsExact identifier
application number: M016
Softlips Tropical CoconutDIMETHICONEThe Mentholatum Company1203ea70-dc1a-4439-a230-bd3fc45f75f52024-12-17WarningsExact identifier
application number: M016
Softlips Tropical Coconut Peach PassionDIMETHICONEThe Mentholatum Company11f619e7-4a58-45e4-8f4a-fe358832ab642024-12-17WarningsExact identifier
application number: M016
Softlips Watermelon, Tropical Coconut, Peach PassionDIMETHICONEThe Mentholatum Companye9212502-909a-4184-905e-f31a53602c3b2024-12-17WarningsExact identifier
application number: M016
Softlips WatermelonDIMETHICONEThe Mentholatum Companye32d738e-e0af-4f17-a753-bdc7938b16842024-12-17WarningsExact identifier
application number: M016
Softlips Peach PassionDIMETHICONEThe Mentholatum Company4a133e73-e51b-4f04-91de-dc8c4d4dba302024-12-17WarningsExact identifier
application number: M016
Sweet Cheeks DiaperZINC OXIDETubby Todd4ed0afe1-c893-453e-b4d5-f32561360ec12024-12-17WarningsExact identifier
application number: M016
White PetrolatumPETROLATUMGeri-Care Pharmaceuticals, Corpf40a29c2-65ea-91f9-e053-2a95a90ac4392024-12-17WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
725145petrolatum 41 % Topical OintmentPSN45878c3c-d05d-984c-e063-6294a90a46611
725145petrolatum 0.41 MG/MG Topical OintmentSCD45878c3c-d05d-984c-e063-6294a90a46611
725145petrolatum 41 % Topical OintmentSY45878c3c-d05d-984c-e063-6294a90a46611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67777-555-0167777055501106 g in 1 TUBE106 gHistorical
67777-555-026777705550224 TUBE in 1 CASE (67777-555-02) / 106 g in 1 TUBE (67777-555-01) 24 tube2025-12-16NoNoCurrent
67777-555-0367777055503396.9 g in 1 JAR396.9 gHistorical
67777-555-046777705550412 JAR in 1 CASE (67777-555-04) / 396.9 g in 1 JAR (67777-555-03) 12 jar2025-12-16NoNoCurrent
67777-555-05677770555050.9 g in 1 PACKET0.9 gHistorical
67777-555-066777705550612 BOX in 1 CASE (67777-555-06) / 144 PACKET in 1 BOX (67777-555-05) / .9 g in 1 PACKET12 box2025-12-16NoNoCurrent