FDA.reportPublic FDA data

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#

NDC, Effective, Related label table
NDCEffectiveRelated label
11701-050-322023-12-21Critic-Aid ® Skin Paste
11701-050-322023-12-21Critic-Aid ® Skin Paste
11701-050-332023-12-21Critic-Aid ® Skin Paste
11701-050-332023-12-21Critic-Aid ® Skin Paste
11701-050-322023-01-30Critic-Aid ® Skin Paste
11701-050-322023-01-30Critic-Aid ® Skin Paste
11701-050-332023-01-30Critic-Aid ® Skin Paste
11701-050-332023-01-30Critic-Aid ® Skin Paste

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#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZCRITIC AID SKIN (ZINC OXIDE) PASTE [COLOPLAST MANUFACTURING US, LLC]6
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZCRITIC AID SKIN (ZINC OXIDE) PASTE [COLOPLAST MANUFACTURING US, LLC]6
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CRITIC AID SKIN (ZINC OXIDE) PASTE [COLOPLAST MANUFACTURING US, LLC]6
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OCRITIC AID SKIN (ZINC OXIDE) PASTE [COLOPLAST MANUFACTURING US, LLC]6
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UCRITIC AID SKIN (ZINC OXIDE) PASTE [COLOPLAST MANUFACTURING US, LLC]6

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 7 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0.25 % PHENYLEPHRINE HCl HEMORRHOIDALMINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.1cada0ae-3f0f-441c-a633-faa0a3009d2b2026-02-05WarningsExact identifier
application number: M015
Numbing CreamLIDOCAINESainite Trading Shenzhen Co., Ltd.49fcbe81-34b6-5906-e063-6294a90aa65b2026-02-04WarningsExact identifier
application number: M015
Perineal Cooling Pad LinersFRIDA MOM PERINEAL COOLING PAD LINERSFridababy, LLCe9d33d92-34ee-b639-e053-2a95a90a9f362026-02-04WarningsExact identifier
application number: M015
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLSportpharm LLC88e3624d-b8bb-4e65-9250-4c51d2bbed162026-02-03WarningsExact identifier
application number: M015
careone hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLAmerican Sales Company46794d2e-8fe6-490d-9cfa-ba9b6c209ad62026-01-29WarningsExact identifier
application number: M015
LUBRICAINE 5LIDOCAINE 5%ESBA LABORATORIES INC.9d98afbf-11ce-745b-e053-2a95a90abc142026-01-28WarningsExact identifier
application number: M015
foster and thrive hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLStrategic Sourcing Services LLC9da843f2-e88c-432e-b091-a6acf81d856b2026-01-22WarningsExact identifier
application number: M015
hemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLHyVee Incbf1beca0-cc9b-4100-9db7-77f2d1e5497c2026-01-21WarningsExact identifier
application number: M015
GRANULOTION HemorrhoidalMENTHOL, ZINC OXIDEGL Health, Inc.1a32741c-5e4a-40e5-b15a-8233c5bdb92b2026-01-19WarningsExact identifier
application number: M015
HydroseptineZINC OXIDE, MENTHOLAKRON PHARMA INC5359d92e-641e-4076-9d91-18daee58a30e2026-01-19WarningsExact identifier
application number: M015
Hemorrhoidal CreamHEMORRHOIDAL CREAMWalgreens1ac2b2ae-c090-483b-ad2c-1374552add4a2026-01-15WarningsExact identifier
application number: M015
WalgreensHEMORRHOIDAL PAIN RELIEFWalgreensb0b1ce47-9fa4-4505-8f38-39a0d500e9f62026-01-15WarningsExact identifier
application number: M015
Hemorrhoidal CreamHEMORRHOIDAL CREAMWalgreens4276ddad-2363-462a-bb97-574f946ec3f02026-01-15WarningsExact identifier
application number: M015
WalgreensHEMORRHOIDAL COOLING GELWalgreens1277d2e8-2a5e-23f5-e063-6294a90a69b02026-01-15WarningsExact identifier
application number: M015
Hemorrhoid and FissureGLYCERIN 6%,LIDOCAINE 4%,ECTOIN 0.12%FlexiGo Inc48697377-61c0-1b0a-e063-6294a90a32932026-01-15WarningsExact identifier
application number: M015
MEDPURA Vitamin A and D Vitamin A and DMEDPURA VITAMIN A AND DAkron Pharma Inc.38cc2317-691b-4657-af05-c67623eba7602026-01-14WarningsExact identifier
application number: M015
Walgreens HemorrhoidalHEMORRHOIDAL RECTAL SUPPOSITORIESWalgreens2dd710ac-ab04-4a24-826f-b5a44d0581682026-01-14WarningsExact identifier
application number: M015
Walgreens HemorrhoidalHEMORRHOIDAL RECTAL SUPPOSITORIESWalgreensca98dea5-767d-49a8-887b-d96cad487fc42026-01-14WarningsExact identifier
application number: M015
Walgreens Moisture BarrierMENTHOL, AND ZINC OXIDEWalgreen Companya6db6f13-4e02-47dc-aef6-a804506c3d8b2026-01-14WarningsExact identifier
application number: M015
GNP Hemorrhoidal Maximum StrengthHEMORRHOIDALAmerisourcebergen Drug Corporation24103355-cd72-55b0-e063-6394a90a90ec2026-01-14WarningsExact 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