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 22 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Family wellness	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	FRONT PHARMACEUTICAL PLC	cfdd61e3-e12e-491c-b2a8-90fae19e8870	2023-10-27	Warnings	Exact identifier application number: M015
Family Wellness	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, PETROLATUM	FRONT PHARMACEUTICAL PLC	eb1785f4-5876-443b-b175-9b59d65d1a48	2023-10-26	Warnings	Exact identifier application number: M015
CVS Health Hemorrhoidal Cream	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	FRONT PHARMACEUTICAL PLC	cb448d78-553c-4e65-80c5-d4b31d7b3661	2023-10-26	Warnings	Exact identifier application number: M015
Family Wellness	PHENYLEPHRINE HCL, PETROLATUM, MINERAL	Zhejiang Jingwei Pharmaceutical Co., Ltd.	bfa195d7-d87f-43b5-bbf1-7ec3a451de05	2023-10-25	Warnings	Exact identifier application number: M015
MAXIMUM STRENGTH HEMORRHOIDAL RELIEF with Finger Cots	LIDOCAINE	CVS PHARMACY, INC	82aa128a-44cd-4907-b0f7-8a31e086d3e6	2023-10-25	Warnings	Exact identifier application number: M015
TheraPlus Plus	PHENYLEPHRINE HCI	Zhejiang Jingwei Pharmaceutical Co., Ltd.	edf9f8d5-f55d-4c31-adfb-ba77ca24cc3d	2023-10-25	Warnings	Exact identifier application number: M015
Assured Bikini Smooth Cream	LIDOCAINE	Zhejiang Jingwei Pharmaceutical Co., Ltd.	fb9ddde3-3f40-467e-8aff-26570144f0fc	2023-10-25	Warnings	Exact identifier application number: M015
Hemorrhoidal Cream	GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUM	Cardinal Health 110, LLC. dba Leader	85a51d5c-679e-1959-e053-2a91aa0a76d5	2023-10-25	Warnings	Exact identifier application number: M015
Family Wellness	GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, PETROLATUM	Zhejiang Jingwei Pharmaceutical Co., Ltd.	fde9cd90-d63c-4058-b46e-511fecea36ec	2023-10-24	Warnings	Exact identifier application number: M015
Lidocaine 5%	LIDOCAINE	Apnar Pharma LP	ceedce20-5723-5a9a-e053-2a95a90a17a1	2023-10-21	Warnings	Exact identifier application number: M015
Numquick Topical Analgesic	EPINEPHRINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE	Unit Dose, Ltd.	3f64cbd3-6745-4397-9767-3adc3b301e0e	2023-10-19	Warnings	Exact identifier application number: M015
Healquick Tattoo Balm	PETROLATUM	Unit Dose, Ltd.	96f92c82-a79a-4d7e-ba0c-5ea67e2b6e86	2023-10-19	Warnings	Exact identifier application number: M015
Numpot Topical Anesthetic	LIDOCAINE, PETROLATUM	Unit Dose, Ltd.	9143b50b-7d76-4545-aa2e-1bb77ffb44ae	2023-10-19	Warnings	Exact identifier application number: M015
Microcaine Topical Analgesic	LIDOCAINE	Unit Dose, Ltd.	5e8fa8b5-0524-4201-91e1-83e59a8f0415	2023-10-19	Warnings	Exact identifier application number: M015
Numstick	PETROLATUM, LIDOCAINE	Unit Dose, Ltd.	127bbd87-5402-4da2-abf3-dac6367735ec	2023-10-18	Warnings	Exact identifier application number: M015
ADVANCED NUMB Topical Anesthetic	LIDOCAINE HYDROCHLORIDE	Uber Scientific, LLC	859d1cad-badf-4c42-9b08-daacb3fae8b4	2023-10-13	Warnings	Exact identifier application number: M015
Hemorrhoidal Pain Relief with Aloe and VitaminE	HEMORRHOIDAL PAIN RELIEF WITH ALOE AND VITAMINE	NeilMed pharmaceuticals Inc.	076b5021-8ba0-0204-e063-6294a90a3337	2023-10-11	Warnings	Exact identifier application number: M015
Zensa Numbing Gel	LIDOCAINE 5%, PHENYLEPHRINE HYDROCHLORIDE 0.25%	Alera Skin Care Products Inc.	065a6eec-3896-0da8-e063-6394a90a849d	2023-09-27	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