FDA.reportPublic FDA data

Critic Aid Clear AF

Product NDC
11701-067
11-digit product format
117010067
Labeler code
11701
Product ID
11701-067_eee5e1de-4094-4113-9079-38f168ddf98f
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Coloplast Corp
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-06-15
Substance
MICONAZOLE NITRATE
Active strength
20 mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Critic Aid Clear AF
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE20 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVW4H1CYW1K
Rxcui998442, 998450

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11701-067-142024-12-26C16284748780-1f386c64a-2867-0266-e053-dadaa90a7c1aCritic-Aid ® Clear AF Antifungal Ointment Clear Moisture Barrier With Antifungal
11701-067-222024-12-26C16284748780-1f386c64a-2867-0266-e053-dadaa90a7c1aCritic-Aid ® Clear AF Antifungal Ointment Clear Moisture Barrier With Antifungal
11701-067-232024-12-26C16284748780-1f386c64a-2867-0266-e053-dadaa90a7c1aCritic-Aid ® Clear AF Antifungal Ointment Clear Moisture Barrier With Antifungal
11701-067-142023-01-30C16284748780-1f386c64a-2867-0266-e053-dadaa90a7c1aCritic-Aid ® Clear AF Antifungal Ointment Clear Moisture Barrier With Antifungal
11701-067-222023-01-30C16284748780-1f386c64a-2867-0266-e053-dadaa90a7c1aCritic-Aid ® Clear AF Antifungal Ointment Clear Moisture Barrier With Antifungal
11701-067-232023-01-30C16284748780-1f386c64a-2867-0266-e053-dadaa90a7c1aCritic-Aid ® Clear AF Antifungal Ointment Clear Moisture Barrier With Antifungal

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11701-067-14Critic Aid Clear AF142 g in 1 TUBEOINTMENT14213
11701-067-22Critic Aid Clear AF4 g in 1 PACKETOINTMENT413
11701-067-23Critic Aid Clear AF57 g in 1 TUBEOINTMENT5713

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11701-067-14GM - Gram11701-067d185bb29-a6ff-48fb-a5ec-1fca7267625112012-07-24
11701-067-22GM - Gram11701-0679f9d37b8-d180-42e0-815f-fbdf8a36392112012-07-24
11701-067-23GM - Gram11701-0677d431067-bdb8-4f06-b2d7-c9e82c18ec4112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MICONAZOLE NITRATEACTIVE INGREDIENTVW4H1CYW1KCRITIC AID CLEAR AF (MICONAZOLE NITRATE) OINTMENT [COLOPLAST MANUFACTURING US, LLC]7
MICONAZOLEACTIVE MOIETY7NNO0D7S5MCRITIC AID CLEAR AF (MICONAZOLE NITRATE) OINTMENT [COLOPLAST MANUFACTURING US, LLC]7
.ALPHA.-TOCOPHEROL ACETATE, D-INACTIVE INGREDIENTA7E6112E4NCRITIC AID CLEAR AF (MICONAZOLE NITRATE) OINTMENT [COLOPLAST MANUFACTURING US, LLC]7
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CRITIC AID CLEAR AF (MICONAZOLE NITRATE) OINTMENT [COLOPLAST MANUFACTURING US, LLC]7
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OCRITIC AID CLEAR AF (MICONAZOLE NITRATE) OINTMENT [COLOPLAST MANUFACTURING US, LLC]7
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UCRITIC AID CLEAR AF (MICONAZOLE NITRATE) OINTMENT [COLOPLAST MANUFACTURING US, LLC]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11701-067CRITIC AID CLEAR AF (MICONAZOLE NITRATE) OINTMENT [COLOPLAST MANUFACTURING US, LLC]9Current NDC, Legacy NDC, 3 package rows20241228_cbc5d976-850a-476e-b179-b7a5a8675524.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998450Critic-Aid Clear AF 2 % Topical OintmentPSNcbc5d976-850a-476e-b179-b7a5a867552413
998442miconazole nitrate 2 % Topical OintmentPSNcbc5d976-850a-476e-b179-b7a5a867552413
998450miconazole nitrate 0.02 MG/MG Topical Ointment [Critic-Aid Clear]SBDcbc5d976-850a-476e-b179-b7a5a867552413
998442miconazole nitrate 0.02 MG/MG Topical OintmentSCDcbc5d976-850a-476e-b179-b7a5a867552413
998450Critic Aid Clear AF 2 % Topical OintmentSYcbc5d976-850a-476e-b179-b7a5a867552413
998450Critic-Aid Clear 0.02 MG/MG Topical OintmentSYcbc5d976-850a-476e-b179-b7a5a867552413
998442miconazole nitrate 2 % Topical OintmentSYcbc5d976-850a-476e-b179-b7a5a867552413

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11701-067-1411701006714142 g in 1 TUBE (11701-067-14) 142 g2009-06-150000-00-00NoNoCurrent
11701-067-22117010067224 g in 1 PACKET (11701-067-22) 4 g2009-06-150000-00-00NoNoCurrent
11701-067-231170100672357 g in 1 TUBE (11701-067-23) 57 g2009-06-150000-00-00NoNoCurrent