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 22 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PetroleumWHITE PETROLATUMHy-Vee, Inc.45867f42-9562-c111-e063-6394a90adb702026-02-04Warnings, Adverse reactionsExact identifier
application number: M016
Daily MoisturizingDIMETHICONELidl US, LLCc82f236d-c27f-458c-bcd8-19877d09e9a32026-02-04Warnings, Adverse reactionsExact identifier
application number: M016
Daily MoisturizingDIMETHICONELidl US, LLC5e83811f-773f-43e7-bab8-f9e558fb0e002026-02-04Warnings, Adverse reactionsExact identifier
application number: M016
CalamineFERRIC OXIDE REDMajor Pharmaceuticalsc25be68d-834a-4959-8d47-01ec789406ba2026-02-04Warnings, Adverse reactionsExact identifier
application number: M016
Petroleum Skin ProtectantWHITE PETROLATUMMajor Pharmaceuticals0e7e11c5-a1f8-43c4-b8a6-2114910524042026-02-04Warnings, Adverse reactionsExact identifier
application number: M016
Witch HazelWITCH HAZELEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)d76e116f-4b22-4633-8487-17ad3b5778c72026-02-04WarningsExact identifier
application number: M016
Comforts Petroleum JellyWHITE PETROLATUMKROGER3feb3638-1cdc-62d4-e063-6294a90a1d892026-02-03WarningsExact identifier
application number: M016
Daily MoisturizingDIMETHICONECVS Pharmacy, Inc.edc20df4-561e-486f-b9f1-900672a0f2a42026-02-03Warnings, Adverse reactionsExact identifier
application number: M016
Colloidal oatmealCOLLOIDAL OATMEALCVS Pharmacy, Inc.a153842c-d9ce-4658-912b-362a6f20b0aa2026-02-03Warnings, Adverse reactionsExact identifier
application number: M016
NeurexaCOLLOIDAL OATMEALMETHODIQ INC.494d7915-acad-260e-e063-6394a90a182c2026-02-03WarningsExact identifier
application number: M016
Thera Plus Vitamin A and D CreamDIMETHICONE, ZINC OXIDEFOURSTAR GROUP USA, INC.36f09fa4-a3b8-4104-9745-ee60aa493b062026-02-02WarningsExact identifier
application number: M016
Vitamin A DLANOLIN, PETROLATUMKroger Co.b4aa9b58-d95e-4dac-9a34-213482e8ca342026-02-02Warnings, Adverse reactionsExact identifier
application number: M016
Nail Nourishing PenGLYCERINShantou Ximonth Biotechnology Co., Ltd.49e45462-a05f-d370-e063-6394a90a1e0f2026-02-02WarningsExact identifier
application number: M016
Barrier Repair CreamCREAMSteel City Health Private Limited4842f653-7137-eca4-e063-6394a90a8c552026-01-31WarningsExact identifier
application number: M016
Cracked Heel Repair BalmDIMETHICONEDelta Brands Inc.42b7c9f8-0557-8e33-e063-6394a90a59192026-01-30WarningsExact identifier
application number: M016
Readybath TPC Total Perineal CareDIMETHICONEMedline Industries, Inc.43a3f0f7-f76f-434d-a21f-7eaa3638913d2026-01-30WarningsExact identifier
application number: M016
Lanolin, PetrolatumLANOLIN, PETROLATUMRite Aid Corporation1b6d7cdf-e7bc-4fd4-939c-5eb0eaa1744d2026-01-30Warnings, Adverse reactionsExact identifier
application number: M016
Zinc OxideZINC OXIDERite Aid Corporation3af9f0e5-0d79-4178-b29e-3b60735bf4ce2026-01-30Warnings, Adverse reactionsExact identifier
application number: M016
Pure petroleumWHITE PETROLATUMRite Aid Corporationf67be4cc-9983-4758-93c8-383919ec07ca2026-01-30Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMRite Aid Corporation0d535736-ba61-42eb-9112-c154295372a22026-01-30Warnings, Adverse reactionsExact 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