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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage11701-067-23ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage11701-067-14ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage11701-067-22ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage11701-067-23367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage11701-067-14367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage11701-067-22367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage11701-067-23557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage11701-067-14557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage11701-067-22557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage11701-067-238af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage11701-067-148af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage11701-067-228af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage11701-067-23834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage11701-067-14834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage11701-067-22834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage11701-067-231332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage11701-067-141332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage11701-067-221332a3947898…d4bfe170f9cd…

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 AF
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE20 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
VW4H1CYW1KInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
998442Internal RxNorm lookup
998450Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cbc5d976-850a-476e-b179-b7a5a8675524Available on FDA.report

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#

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#

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

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 16 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EXTRA STRENGTH TOENAIIL RENEWAL PENUNDECYLENIC ACID, TOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD4eea5ee7-0ef9-8d34-e063-6294a90af5952026-04-07WarningsExact identifier
application number: M005
EXTRA STRENGTH TOENAIIL RENEWAL SolutionUNDECYLENIC ACID, TOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD4eeaa2f0-efc7-eab3-e063-6294a90a13b32026-04-07WarningsExact identifier
application number: M005
Extra Strength Toenail Renewal PenUNDECYLENIC ACID, TOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD4eeb59d2-3891-2e45-e063-6294a90a4fcf2026-04-07WarningsExact identifier
application number: M005
RoyceDerm Tinea ANTIFUNGAL .soap.CLOTRIMAZOLE 1%RoyceDerm LLC4e889f2b-9ea1-b1a6-e063-6394a90a46542026-04-03WarningsExact identifier
application number: M005
Toenail Fungus Treatment Extra Strength PenTOLNAFTATE, UNDECYLENIC ACIDLianjiang Shanlilai E-commerce Co., Ltd.28fbcc50-a3ac-d6d1-e063-6294a90aa2b62026-04-02WarningsExact identifier
application number: M005
TOENAIL FUNGUS TREATMENT LiquidTOLNAFTATE, UNDECYLENIC ACIDLianjiang Shanlilai E-commerce Co., Ltd.28fc7049-e367-42bf-e063-6394a90a6f062026-04-02WarningsExact identifier
application number: M005
Fungal Nail PatchesTOLNAFTATE, UNDECYLENIC ACIDLianjiang Shanlilai E-commerce Co., Ltd.299a63ad-f321-117c-e063-6394a90a3a222026-04-02WarningsExact identifier
application number: M005
Secura Antifungal GreaselessMICONAZOLE NITRATESmith & Nephew Medical Ltd9be600e4-76ec-4071-a8ec-a0b23155271d2026-04-02WarningsExact identifier
application number: M005
FifthPulse Bacitracin ZincBACITRACIN ZINCWeCare Products LLC5c6b3ad8-c158-4cc0-b1ba-b829b5df12842026-04-02WarningsExact identifier
application number: M005
FifthPulse Miconazole Nitrate AntifungalMICONAZOLE NITRATEWeCare Products LLCb70238eb-afcb-4e09-976f-973df249241c2026-04-02WarningsExact identifier
application number: M005
ANTIFUNGAL PENUNDECYLENIC ACID, TERBINAFINE HYDROCHLORIDEHanyang Qisheng (Shenzhen) Technology Co., Ltd.4e85f338-ffd7-85b1-e063-6294a90a3c872026-04-02WarningsExact identifier
application number: M005
RoyceDerm Anti-Fungal CreamMICONAZOLE NITRATE 2%RoyceDerm LLC4e861073-88e8-b2f7-e063-6394a90ab94a2026-04-02WarningsExact identifier
application number: M005
Miconazole NitrateJOCK ITCH SPRAYCVS Pharmacy7b70d3ea-126a-42aa-8509-b982893c710b2026-04-01WarningsExact identifier
application number: M005
Fungicure Anti-Fungal LiquidTOLNAFTATEKobayashi Healthcare International, Inc.b18ee199-0659-733c-e053-2a95a90ab6b52026-04-01WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYCVS Pharmacy96cc594d-85c8-4f62-bc0a-3176c8739f212026-04-01WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE POWDER SPRAYCVS Pharmacya7b6bd7c-23db-43e1-92f7-e27f5f4801de2026-04-01WarningsExact identifier
application number: M005
Baza AntifungalMICONAZOLE NITRATEColoplast Corp75182cb7-840a-423a-9c20-10840d6e1d652026-03-31WarningsExact identifier
application number: M005
MICONAZOLE Nitrate 2% Cream ANTIFUNGALMICONAZOLE NITRATETrifecta Pharmaceuticals Usa Llc80217dbb-a0f0-414a-8d22-a9a346b017aa2026-03-31WarningsExact identifier
application number: M005
RoyceDerm Antifungal BarCLOTRIMAZOLERoyceDerm LLC3abdc4a8-58dd-5bd0-e063-6294a90a1bca2026-03-31WarningsExact identifier
application number: M005
Critic Aid Clear AFMICONAZOLE NITRATEColoplast Corpcbc5d976-850a-476e-b179-b7a5a86755242026-03-31WarningsExact identifier
application number: M005
ndc (product): 11701-067

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