FDA.reportPublic FDA data

Critic Aid Clear

Product NDC
11701-066
11-digit product format
117010066
Labeler code
11701
Product ID
11701-066_5a52f10b-cf1f-4c6e-a662-505beb528d2a
Type
HUMAN OTC DRUG
Nonproprietary name
Petrolatum
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Coloplast Corp
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-06-15
Substance
PETROLATUM
Active strength
710 mg/g
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
Critic Aid Clear
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM710 mg/g

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
686452Internal RxNorm lookup
1053000Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0b6da97e-519b-4579-9895-f4ede5c48b47Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
11701-066-222023-12-21Critic-Aid ® Clear Skin Protectant Clear Moisture Barrier Ointment
11701-066-322023-12-21Critic-Aid ® Clear Skin Protectant Clear Moisture Barrier Ointment
11701-066-332023-12-21Critic-Aid ® Clear Skin Protectant Clear Moisture Barrier Ointment
11701-066-222023-01-30Critic-Aid ® Clear Skin Protectant Clear Moisture Barrier Ointment
11701-066-322023-01-30Critic-Aid ® Clear Skin Protectant Clear Moisture Barrier Ointment
11701-066-332023-01-30Critic-Aid ® Clear Skin Protectant Clear Moisture Barrier Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11701-066-22Critic Aid Clear4 g in 1 PACKETOINTMENT47
11701-066-32Critic Aid Clear170 g in 1 TUBEOINTMENT1707
11701-066-33Critic Aid Clear71 g in 1 TUBEOINTMENT717

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11701-066-22GM - Gram11701-06684478602-2e57-4d1d-a8c5-3ee34398424812012-07-24
11701-066-32GM - Gram11701-06622339e53-526e-4c45-9d06-56436883b76e12012-07-24
11701-066-33GM - Gram11701-066ee97a8dc-3c0b-4d46-9170-785a8cceee9a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PETROLATUMACTIVE INGREDIENT4T6H12BN9UCRITIC AID CLEAR (PETROLATUM) OINTMENT [COLOPLAST MANUFACTURING US, LLC]4
PETROLATUMACTIVE MOIETY4T6H12BN9UCRITIC AID CLEAR (PETROLATUM) OINTMENT [COLOPLAST MANUFACTURING US, LLC]4
.ALPHA.-TOCOPHEROL ACETATE, D-INACTIVE INGREDIENTA7E6112E4NCRITIC AID CLEAR (PETROLATUM) OINTMENT [COLOPLAST MANUFACTURING US, LLC]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CRITIC AID CLEAR (PETROLATUM) OINTMENT [COLOPLAST MANUFACTURING US, LLC]4
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OCRITIC AID CLEAR (PETROLATUM) OINTMENT [COLOPLAST MANUFACTURING US, LLC]4
ZINC OXIDEINACTIVE INGREDIENTSOI2LOH54ZCRITIC AID CLEAR (PETROLATUM) OINTMENT [COLOPLAST MANUFACTURING US, LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11701-066CRITIC AID CLEAR (PETROLATUM) OINTMENT [COLOPLAST MANUFACTURING US, LLC]6Current NDC, Legacy NDC, 3 package rows20231222_0b6da97e-519b-4579-9895-f4ede5c48b47.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 14 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChapStick Classic Variety-Classic Cherry-Classic Strawberry-Classic SpearmintSKIN PROTECTANT LIP BALMSuave Brands Co., LLC4523af69-1a0d-6d18-e063-6394a90ad9d12026-03-30WarningsExact identifier
application number: M016
ChapStick Sweet Valetine Berry Much Besties, Mint To Be, Cherish Me CherryLIP BALM SKIN PROTECTANTSuave Brands Company47a2487d-b2e5-7195-e063-6394a90ae4812026-03-30WarningsExact identifier
application number: M016
ChapStick Classic CherrySKIN PROTECTANT LIP BALMSuave Brands Co., LLC4512b5a0-ce1f-c53e-e063-6294a90a56b62026-03-30WarningsExact identifier
application number: M016
ChapStick Classic StrawberrySKIN PROTECTANT LIP BALMSuave Brands Co., LLC42770fff-d70a-d9d1-e063-6294a90aa98d2026-03-30WarningsExact identifier
application number: M016
Aveeno Skin Relief HealingGLYCERINKenvue Brands LLC345fdde5-700b-7103-e063-6394a90a0e3e2026-03-27WarningsExact identifier
application number: M016
Critic Aid ClearPETROLATUMColoplast Corp0b6da97e-519b-4579-9895-f4ede5c48b472026-03-27WarningsExact identifier
application number: M016
ndc (product): 11701-066
Baza ProtectZINC OXIDE AND DIMETHICONEColoplast Corp256dfcfc-a91c-49b0-9439-452586a0880e2026-03-27WarningsExact identifier
application number: M016
Sween 24DIMETHICONEColoplast Corpa623c8d7-8db0-410a-9980-02ac02f7b6ea2026-03-27WarningsExact identifier
application number: M016
Baza Cleanse and Protect Odor ControlDIMETHICONEColoplast Corpca5fa4ae-c18d-4457-b520-4a9318ea821f2026-03-27WarningsExact identifier
application number: M016
Baza Cleanse and ProtectDIMETHICONEColoplast Corp82eff041-0c9d-4261-a6b6-5a041a6600742026-03-27WarningsExact identifier
application number: M016
Baza ClearPETROLATUMColoplast Corp69d9f456-1a35-4146-8366-c0285648a1722026-03-27WarningsExact identifier
application number: M016
Vitamin A DLANOLIN, PETROLATUMTopco Associates LLC5126fdf6-5df5-474b-bc0d-3a82dea61abb2026-03-26Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMAmazon.com Services LLCcdf1bd12-ac59-4f06-be0f-ef6eb3caeeff2026-03-26Warnings, Adverse reactionsExact identifier
application number: M016
Dynashield with DimethiconeZINC OXIDEDynarex Corporationb5dcf9e8-4689-4a08-ae73-3a859b4cbffe2026-03-26WarningsExact identifier
application number: M016
Eczema Relief CreamCOLLOIDAL OATMEALLavior Pharma Incbdd2fc9f-2718-1d88-e053-2995a90a86822026-03-26WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC36f2dec8-7ffc-fc3e-e063-6294a90a76ff2026-03-26WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC36f33001-7fec-682e-e063-6394a90a94282026-03-26WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC36f3b300-f32f-8881-e063-6394a90a1a2a2026-03-26WarningsExact identifier
application number: M016
White PetrolatumPETROLATUMDynarex Corporation81f5092d-0632-bf47-e053-2991aa0ac5632026-03-25WarningsExact identifier
application number: M016
MYEVERESTRIOL CREAMHubei Redrui Building Materials Co., Ltd.3ed85485-a441-4c05-e063-6394a90afef52026-03-25WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053000Critic-Aid Clear Moisture Barrier 71.5 % Topical OintmentPSN0b6da97e-519b-4579-9895-f4ede5c48b477
686452petrolatum 71.5 % Topical OintmentPSN0b6da97e-519b-4579-9895-f4ede5c48b477
1053000petrolatum 0.715 MG/MG Topical Ointment [Critic-Aid Clear Moisture]SBD0b6da97e-519b-4579-9895-f4ede5c48b477
686452petrolatum 0.715 MG/MG Topical OintmentSCD0b6da97e-519b-4579-9895-f4ede5c48b477
1053000Critic-Aid Clear Moisture 0.715 MG/MG Topical OintmentSY0b6da97e-519b-4579-9895-f4ede5c48b477
1053000Critic-Aid Clear Moisture Barrier 71.5 % OintmentSY0b6da97e-519b-4579-9895-f4ede5c48b477
686452petrolatum 71.5 % Topical OintmentSY0b6da97e-519b-4579-9895-f4ede5c48b477

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11701-066-22117010066224 g in 1 PACKET (11701-066-22) 4 g2009-06-150000-00-00NoNoCurrent
11701-066-3211701006632170 g in 1 TUBE (11701-066-32) 170 g2009-06-150000-00-00NoNoCurrent
11701-066-331170100663371 g in 1 TUBE (11701-066-33) 71 g2009-06-150000-00-00NoNoCurrent