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 29 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aquaphor OriginalPETROLATUMBeiersdorf Incd38ec874-7b8c-4b9b-92b6-286278bb67f32025-12-15WarningsExact identifier
application number: M016
Aquaphor Healing Diaper RashZINC OXIDEBeiersdorf Incdec07dfc-67a2-46ad-8fab-828488bdba152025-12-15WarningsExact identifier
application number: M016
HealthWise Diabetic Foot CreamDIMETHICONE, PETROLATUMVeridian Healthcare7ba0ac53-c78c-4a70-a977-a082f731919e2025-12-15WarningsExact identifier
application number: M016
Aquaphor Lip Protectant and SunscreenPETROLATUM, AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEBeiersdorf Inca43c2802-9cf1-477e-9f93-e11cf40b480d2025-12-15WarningsExact identifier
application number: M016
Prequel Barrier Therapy Rich Skin Protectant CreamSKIN PROTECTANT CREAMThe Center Brands, LLC39945806-8f29-020b-e063-6294a90a9fc62025-12-13WarningsExact identifier
application number: M016
ECZEMACOLLOIDAL OATMEALSmith Amish, LLC20c4bc16-ba20-47ec-e063-6394a90a8b4e2025-12-12WarningsExact identifier
application number: M016
Humco CalagesicCALAMINE AND PRAMOXINE HYDROCHLORIDEHumco Holding Group, Inc.8c43590d-56ec-4588-8076-99ba94a166852025-12-11WarningsExact identifier
application number: M016
Soteri Skin Baby Eczema Relief CreamCOLLOIDAL OATMEALSoteri Skin, Inc41d88ff2-22aa-8447-e063-6294a90aea0e2025-12-10WarningsExact identifier
application number: M016
Soteri Skin Active Flare-Up Eczema Relief CreamCOLLOIDAL OATMEALSoteri Skin, Inc.41b558d9-55ba-97ff-e063-6394a90a963b2025-12-10WarningsExact identifier
application number: M016
CeraVe Developed With Dermatologist Baby Eczema Relief CreamOATMEALL'Oreal USA Products Inc5d392529-9f0c-40bc-92ca-7003f8e64b1c2025-12-09WarningsExact identifier
application number: M016
CeraVe Developed with Dermatologists Eczema Relief MoisturizingCOLLOIDAL OATMEALL'Oreal USA Products Incc4dde987-fe4e-4f8e-8f3a-1bc12c9588ed2025-12-09WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Intense Hydration Skin ProtectantCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company446ddb19-4bdb-6827-e063-6394a90a6af82025-12-09WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Warm VanillaCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company45864832-51bb-4e24-e063-6294a90ab5542025-12-09WarningsExact identifier
application number: M016
AquaSootheAQUASOOTHEDynarex Corporation45878c3c-d05d-984c-e063-6294a90a46612025-12-09WarningsExact identifier
application number: M016
ndc (product): 67777-555
Soteri Skin Long-Term Eczema Relief CreamCOLLOIDAL OATMEALSoteri Skin, Inc41d752cb-3866-e840-e063-6394a90acc372025-12-09WarningsExact identifier
application number: M016
Earths Care EczemaOATMEALDLC Laboratories, Inc.f72e2adf-8930-458f-a6cc-9b240b2f5eba2025-12-08WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Sparkling GrapefruitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company4575ba40-009c-26e0-e063-6394a90adee62025-12-08WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Chai CinnamonCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company4576cd28-9531-4db4-e063-6394a90a9fd32025-12-08WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin ProtectantCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Companybeb22d69-8a83-65dc-e053-2a95a90ad8122025-12-08WarningsExact identifier
application number: M016
Medicated Hemorrhoidal PadsWITCH HAZELCardinal Health0b49db40-7abc-4e62-b6da-4b9f5b0ae16d2025-12-05WarningsExact 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