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
Ingredient	Strength
ZINC OXIDE	200 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SOI2LOH54Z	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
caaac1f0-437d-4185-8670-9f11b9cefe63	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
11701-050-32	2023-12-21	Critic-Aid ® Skin Paste
11701-050-32	2023-12-21	Critic-Aid ® Skin Paste
11701-050-33	2023-12-21	Critic-Aid ® Skin Paste
11701-050-33	2023-12-21	Critic-Aid ® Skin Paste
11701-050-32	2023-01-30	Critic-Aid ® Skin Paste
11701-050-32	2023-01-30	Critic-Aid ® Skin Paste
11701-050-33	2023-01-30	Critic-Aid ® Skin Paste
11701-050-33	2023-01-30	Critic-Aid ® Skin Paste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
11701-050-32	Critic Aid Skin	170 g in 1 TUBE	PASTE	170		11
11701-050-33	Critic Aid Skin	71 g in 1 TUBE	PASTE	71		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11701-050-32	GM - Gram	11701-050	84b0b25f-ad8a-46b7-846d-a7e589b2a9d4	1	2012-07-24
11701-050-33	GM - Gram	11701-050	cb38b322-2b6c-4574-b50c-ac345c92219c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	CRITIC AID SKIN (ZINC OXIDE) PASTE [COLOPLAST MANUFACTURING US, LLC]	6
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	CRITIC AID SKIN (ZINC OXIDE) PASTE [COLOPLAST MANUFACTURING US, LLC]	6
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CRITIC AID SKIN (ZINC OXIDE) PASTE [COLOPLAST MANUFACTURING US, LLC]	6
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	CRITIC AID SKIN (ZINC OXIDE) PASTE [COLOPLAST MANUFACTURING US, LLC]	6
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	CRITIC AID SKIN (ZINC OXIDE) PASTE [COLOPLAST MANUFACTURING US, LLC]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11701-050	CRITIC AID SKIN (ZINC OXIDE) PASTE [COLOPLAST MANUFACTURING US, LLC]	9	Current NDC, Legacy NDC, 2 package rows	20231222_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 19 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Meijer Distribution Inc	14319ba4-3bce-497c-a380-65bd24defc5d	2024-10-17	Warnings	Exact identifier application number: M015
equate hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Wal-Mart Stores Inc	581dd76f-d052-4448-8139-9a2e31891b25	2024-10-17	Warnings	Exact identifier application number: M015
Equate Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Wal-Mart Stores Inc	81ecb091-38da-4b3e-a0a1-b4986b97ee09	2024-10-16	Warnings	Exact identifier application number: M015
Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Kroger Company	5c81d564-f786-46e1-af8b-f47521fbae60	2024-10-16	Warnings	Exact identifier application number: M015
topcare hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Topco Associates LLC	615e87e4-79e0-44d6-b563-3bcd5a9b2d93	2024-10-16	Warnings	Exact identifier application number: M015
Basic Care Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Amazon.com Services LLC	fe675174-fc95-4dd7-bd39-c209c6ce0f6c	2024-10-16	Warnings	Exact identifier application number: M015
hemorrhoidal	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	Meijer Distribution Inc	fb170371-2e5d-43ca-a259-538a973ee3b8	2024-10-15	Warnings	Exact identifier application number: M015
topcare hemorrhoidal	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	Topco Associates LLC	5e13da07-48cf-40bc-bb11-fd891886cbea	2024-10-14	Warnings	Exact identifier application number: M015
hemorrhoidal maximum strength pain relief	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	Kroger Company	3c8f90e2-fecf-4439-9faa-81a32ffe4753	2024-09-26	Warnings	Exact identifier application number: M015
equate hemorrhoidal	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	Wal-Mart Stores Inc	5ccefdbd-bbbe-4cbf-9fdb-3c568643e14d	2024-09-26	Warnings	Exact identifier application number: M015
Walgreens Hemorrhoidal Pain Relief	GLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%	Walgreens	e79ed7ae-0d06-2f88-e053-2995a90a1e35	2024-09-20	Warnings	Exact identifier application number: M015
hemorrhoidal relief	COCOA BUTTER, PHENYLEPHRINE HCL	Rite Aid Corporation	ddafbdca-32c2-49c1-83d3-35b4155958c9	2024-08-15	Warnings	Exact identifier application number: M015
Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Rite Aid Corporation	8e1f223a-a3a0-4837-9847-2a3939fcc595	2024-08-15	Warnings	Exact identifier application number: M015
Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Bryant Ranch Prepack	485fd02f-bfea-41d0-90a1-f12fcfeb2a15	2024-08-14	Warnings	Exact identifier application number: M015
Up and Up Hemorrhoid MAX STRENGTH	14.4% GLYCERIN, 0.25% PHENYLEPHRINE HCL, 1% PRAMOXINE HCL, 15% PETROLATUM	Target Corporation	867677b5-fd1d-449e-966e-1de0b5c98afb	2024-08-08	Warnings	Exact identifier application number: M015
Soothing Hemorrhoidal Wipes 50 Witch Hazel	WITCH HAZEL	The Honey Pot Company LLC	1ea202f5-e228-b3f2-e063-6294a90a16c1	2024-08-01	Warnings	Exact identifier application number: M015
Bunnies Bum Hemorrhoidal Numbing	LIDOCAINE	FloCal Distributors LLC	1c809643-0cbe-568f-e063-6394a90a3210	2024-07-05	Warnings	Exact identifier application number: M015
Bunnies Bum Soothing Hemorrhoidal	GLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCL	FloCal Distributors LLC	1c81582c-7ece-182f-e063-6294a90a8fbc	2024-07-05	Warnings	Exact identifier application number: M015
MegaBabe Butt Stuff Hemorrhoidal	COCOA BUTTER, GLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE	MEGABABE, LLC	01c156ff-69f9-4d5e-a9ea-abbc52d4afff	2024-06-12	Warnings	Exact identifier application number: M015
PUREGEN LABS Maximum Strength Lidocaine	LIDOCAINE	Advanced Rx LLC	f4f89582-49e6-424a-bea7-0694484a7c99	2024-04-11	Warnings	Exact identifier application number: M015

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1486031	Critic-aid Skin 20 % Paste	PSN	caaac1f0-437d-4185-8670-9f11b9cefe63	11
416684	zinc oxide 20 % Topical Paste	PSN	caaac1f0-437d-4185-8670-9f11b9cefe63	11
1486031	zinc oxide 0.2 MG/MG Paste [Critic-Aid Skin]	SBD	caaac1f0-437d-4185-8670-9f11b9cefe63	11
416684	zinc oxide 0.2 MG/MG Paste	SCD	caaac1f0-437d-4185-8670-9f11b9cefe63	11
1486031	Critic-aid Skin 0.2 MG/MG Paste	SY	caaac1f0-437d-4185-8670-9f11b9cefe63	11
1486031	Critic-aid Skin 20 % Paste	SY	caaac1f0-437d-4185-8670-9f11b9cefe63	11
416684	zinc oxide 20 % Topical Paste	SY	caaac1f0-437d-4185-8670-9f11b9cefe63	11
416684	ZNO 0.2 MG/MG Paste	SY	caaac1f0-437d-4185-8670-9f11b9cefe63	11
1486031	ZNO 0.2 MG/MG Paste [Critic-aid Skin]	SY	caaac1f0-437d-4185-8670-9f11b9cefe63	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11701-050-32	11701005032	170 g in 1 TUBE (11701-050-32)	170 g	2009-06-15	0000-00-00	No	No	Current
11701-050-33	11701005033	71 g in 1 TUBE (11701-050-33)	71 g	2009-06-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Critic-Aid ® Skin Paste	Coloplast Corp \| Coloplast Corp. \| Medline Industries, LP	2026-03-30	HUMAN OTC DRUG LABEL	11