Critic Aid Skin

Product NDC
11701-050
11-digit product format
117010050
Labeler code
11701
Product ID
11701-050_e6597ee1-bc01-495b-b5f3-1503de8f37f2
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc oxide
Dosage form
PASTE
Route
TOPICAL
Labeler
Coloplast Corp
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-06-15
Substance
ZINC OXIDE
Active strength
200 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 Skin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE200 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
416684Internal RxNorm lookup
1486031Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
caaac1f0-437d-4185-8670-9f11b9cefe63Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11701-050-32Critic Aid Skin170 g in 1 TUBEPASTE17011
11701-050-33Critic Aid Skin71 g in 1 TUBEPASTE7111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11701-050-32GM - Gram11701-05084b0b25f-ad8a-46b7-846d-a7e589b2a9d412012-07-24
11701-050-33GM - Gram11701-050cb38b322-2b6c-4574-b50c-ac345c92219c12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11701-050CRITIC AID SKIN (ZINC OXIDE) PASTE [COLOPLAST MANUFACTURING US, LLC]9Current NDC, Legacy NDC, 2 package rows20231222_caaac1f0-437d-4185-8670-9f11b9cefe63.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 21 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mayinglong HemorrhoidalPETROLATUM, ZINC OXIDEMayinglong Pharmaceutical Group Co., Ltd.b14192ea-1bf7-da6a-e053-2a95a90a5b5e2023-12-08WarningsExact identifier
application number: M015
Hemorrhoidal cooling gelPHENYLEPHRINE HCL, WITCH HAZELWALGREENS03bbe258-e00d-13cc-e063-6394a90ae3452023-12-05WarningsExact identifier
application number: M015
Hemorrhoidal Pain ReliefMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLWALGREENS03bc5c1a-d493-5082-e063-6394a90ae87b2023-12-05WarningsExact identifier
application number: M015
Bloop Hemorrhoid Relief TopicalGLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCLThree Nations Corp0b6419e3-f1c7-bdfe-e063-6294a90a5d922023-11-30WarningsExact identifier
application number: M015
Bloop Fissure Healing Anorectal TopicalLIDOCAINEThree Nations Corp0b645092-ebc4-e4bb-e063-6294a90ad4cf2023-11-30WarningsExact identifier
application number: M015
SIMPLY VITAL HEMORRHOID and ANORECTAL RELIEFLIDOCAINEALPHA PLANTS INC79fa4b89-382f-45fa-a792-90a9fe5bf5732023-11-11WarningsExact identifier
application number: M015
BODY ACTION PRODUCTS Prolong LubricatingBENZOCAINEPRODUCT MAX GROUP INC3bef5915-1c98-4011-baa9-ad0bbef200c22023-11-10WarningsExact identifier
application number: M015
BODY ACTION PRODUCTS Butt Eze BenzocaineBENZOCAINEPRODUCT MAX GROUP INCba75b129-7939-4373-91f5-1772976e6d612023-11-10WarningsExact identifier
application number: M015
Uber Numb Topical AnestheticLIDOCAINE HYDROCHLORIDEUberScientific, LLC441c802f-a363-1530-e054-00144ff88e882023-11-10WarningsExact identifier
application number: M015
Uber Numb Topical AnestheticLIDOCAINE HYDROCHLORIDEUberScientific, LLC4939a547-c94b-3350-e054-00144ff88e882023-11-10WarningsExact identifier
application number: M015
DR REAL NUMB Topical AnorectalLIDOCAINEFUZZYLULU LLC378d8edc-2120-416d-854c-8881c2950efe2023-11-09WarningsExact identifier
application number: M015
The Pharma C Company Medicated Foam with Witch HazelWITCH HAZELKleen Test Products Corporation1a1fbe83-be45-4654-a7bb-e934e1ccd0c62023-11-09WarningsExact identifier
application number: M015
The Pharma-C Company Medicated Hemorrhoidal PadsWITCH HAZELKleen Test Products Corporation357703ab-4e7a-41f6-9ecf-aa98acc2d92e2023-11-09WarningsExact identifier
application number: M015
DOCTORS TOUCH Erase The Pain LidocaineLIDOCAINE HYDROCHLORIDEDOCTOR'S CHOICE MEDICAL, LLC3dc9947b-8196-4a38-97b4-c2340ee77e0f2023-11-06WarningsExact identifier
application number: M015
SCALAR Pain Relief CreamMENTHOLMiracle Balance, LLC52a13cfe-3f46-45f8-a5af-ce07ea5758e32023-11-06WarningsExact identifier
application number: M015
SIMPLE PROMISE Simple H Hemorrhoid Relief CreamPHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDESIMPLE PROMISE PTE LTDf6622caa-3b31-9b07-e053-2a95a90a8a512023-11-06WarningsExact identifier
application number: M015
WAXUP NumbingLIDOCAINE HYDROCHLORIDECONSTRUSOLUTION, LLC4f1645ab-1b19-4d69-99c3-9ea275b01a872023-11-06WarningsExact identifier
application number: M015
SECONDARY NUMB Lidocaine Phenylephrine GelLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDELALANI Rx Consulting, Inc.0f13f7b5-e3b1-451e-a6d6-e7e15bd044432023-11-06WarningsExact identifier
application number: M015
Brazzers Anal DesensitizingLIDOCAINEMetro Media Entceacd80c-0dd6-4e21-97da-56da877b1c902023-11-06WarningsExact identifier
application number: M015
NUMB PLUS Maximum Strength AnorectalLIDOCAINESEENEXT VENTURE LTDa7c37b2a-b647-43d7-b43b-87bbece354302023-11-05WarningsExact identifier
application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1486031Critic-aid Skin 20 % PastePSNcaaac1f0-437d-4185-8670-9f11b9cefe6311
416684zinc oxide 20 % Topical PastePSNcaaac1f0-437d-4185-8670-9f11b9cefe6311
1486031zinc oxide 0.2 MG/MG Paste [Critic-Aid Skin]SBDcaaac1f0-437d-4185-8670-9f11b9cefe6311
416684zinc oxide 0.2 MG/MG PasteSCDcaaac1f0-437d-4185-8670-9f11b9cefe6311
1486031Critic-aid Skin 0.2 MG/MG PasteSYcaaac1f0-437d-4185-8670-9f11b9cefe6311
1486031Critic-aid Skin 20 % PasteSYcaaac1f0-437d-4185-8670-9f11b9cefe6311
416684zinc oxide 20 % Topical PasteSYcaaac1f0-437d-4185-8670-9f11b9cefe6311
416684ZNO 0.2 MG/MG PasteSYcaaac1f0-437d-4185-8670-9f11b9cefe6311
1486031ZNO 0.2 MG/MG Paste [Critic-aid Skin]SYcaaac1f0-437d-4185-8670-9f11b9cefe6311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11701-050-3211701005032170 g in 1 TUBE (11701-050-32) 170 g2009-06-150000-00-00NoNoCurrent
11701-050-331170100503371 g in 1 TUBE (11701-050-33) 71 g2009-06-150000-00-00NoNoCurrent