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 42 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
terrasil Diabetics Ulcer and Sore ReliefALLANTOINAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutionsfd6bf169-f1e2-48d4-b98d-8f3c39981a892025-05-23WarningsExact identifier
application number: M016
Perfect 10 Soothing RecoveryPETROLATUMTopiderm, Inc.e3a4f038-d084-4d77-bd35-13f41856a6152025-04-30WarningsExact identifier
application number: M016
Diabetic Advanced Healing CreamDIMETHICONENeoteric Cosmetics, Inc.46996845-9398-41d8-bf99-79f6a29bec282025-04-30WarningsExact identifier
application number: M016
BabyDiaperCreamBABY DIAPER CREAMWhole Foods Marketd7b19529-d0b2-638b-e053-2a95a90acf2f2025-04-29WarningsExact identifier
application number: M016
ChapIce Moisture SPF 15 Lip BalmOXYBENZONE, OCTINOXATE, PETROLATUMNavajo Manufacturing Company Inc.60ce1a8c-180a-161e-e053-2991aa0ae9812025-04-29WarningsExact identifier
application number: M016
Assurance Barrier CreamDIMETHICONE CREAMWalmart Inc23a2a04f-71ce-4fa1-e063-6394a90a649e2025-04-22WarningsExact identifier
application number: M016
Aveeno Baby Eczema Therapy MoisturizingOATMEALKenvue Brands LLC21d2c0a0-70c3-7fd3-e063-6394a90a46d42025-04-18WarningsExact identifier
application number: M016
Secura Extra ProtectiveZINC OXIDESmith & Nephew Medical Ltd499a1944-1682-4798-9058-3748a5eaa4202025-04-17WarningsExact identifier
application number: M016
Firming Care GelFIRMING CARE GELGuangzhou Jiaan Cosmetics Co.,Ltd.32cb8a71-81cd-cdbd-e063-6394a90ac07f2025-04-15WarningsExact identifier
application number: M016
Baby Mantra Diaper CreamZINC OXIDE 10%Renu Laboratories, LLC0427bbc9-f4c0-0eb6-e063-6294a90a71992025-04-14WarningsExact identifier
application number: M016
Witch HazelWITCH HAZELTOP CARE (Topco Associates LLC)23b592f7-3af3-45ef-897a-fe33ab518b6d2025-04-14WarningsExact identifier
application number: M016
Witch HazelWITCH HAZELStrategic Sourcing Services LLCef3408db-de98-4a43-9215-f80fed14815c2025-04-14WarningsExact identifier
application number: M016
Petroleum JellyPETROLATUMWalgreens69bdd508-7c33-42c5-9a08-e56cf3eaebf32025-04-11WarningsExact identifier
application number: M016
4% 10gTATTOO Numb Cream4% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD322daa32-a74e-1fee-e063-6294a90a37aa2025-04-07WarningsExact identifier
application number: M016
Aluroderm ScarALLANTOINAsclemed USA, Inc.60656ca1-5218-4595-854e-19f1061def1e2025-04-01WarningsExact identifier
application number: M016
Dr. Maxs DiaperZINC OXIDEDr. Maxs LLC31bfa962-5e3b-c5d2-e063-6294a90ac1772025-04-01WarningsExact identifier
application number: M016
VaselineBABY HEALING JELLYConopco Inc. d/b/a Unileverbca3176f-86fe-5969-e053-2995a90a24192025-03-31WarningsExact identifier
application number: M016
4% TATTOO Numb Cream4% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD31646815-f591-c560-e063-6294a90ad11a2025-03-28WarningsExact identifier
application number: M016
Face Saver GelSKIN PROTECTANT GELNeat Feat Products Limited31563dd7-9f58-80f6-e063-6294a90a55712025-03-27WarningsExact identifier
application number: M016
PorphoseCOLLOIDAL OATMEAL TOPICAL SPRAYPorphose315951e0-899f-c968-e063-6294a90abe612025-03-27WarningsExact 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