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 16 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Calmoseptine	ANORECTAL OINTMENT	Calmoseptine Inc.	ff9539ed-d9ae-401d-adbc-df8f1d751431	2025-01-13	Warnings	Exact identifier application number: M015
Dibucaine	DIBUCAINE	Akron Pharma Inc.	60469e43-ab6f-46d3-a1df-00e58275f565	2025-01-12	Warnings	Exact identifier application number: M015
Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI	Chain Drug Marketing Association Inc.	2b490a08-149d-76ab-e063-6394a90a084f	2025-01-09	Warnings	Exact identifier application number: M015
Drs. pharmacy HEMORRHOIDAL COOLING	PHENYLEPHRINE HCL, WITCH HAZEL	OL PHARMA TECH, LLC Drs PHARMACY	d6f6b482-d85d-001c-e053-2995a90ad98c	2025-01-09	Warnings	Exact identifier application number: M015
Hemorrhoidal Cream with Aloe	GLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUM	Chain Drug Marketing Association	2b33c710-ac17-20f9-e063-6294a90ad29c	2025-01-08	Warnings	Exact identifier application number: M015
THE SOLUTION	LIDOCAINE HYDROCHLORIDE, EPINEPHRINE HYDROCHLORIDE	SCALP TECH INC	df51623c-e0b6-8e86-e053-2995a90a59b2	2025-01-08	Warnings	Exact identifier application number: M015
frida mom Perineal Cooling Pad Liners	WITCH HAZEL	Fridababy, LLC	a461ff3d-e115-4f15-a545-bacb502ff6cd	2024-12-30	Warnings	Exact identifier application number: M015
frida mom Postpartum Recovery Essentials	WITCH HAZEL	Fridababy, LLC	2d26c6f2-5d31-4c07-9f40-2fbfcfbf1234	2024-12-30	Warnings	Exact identifier application number: M015
frida mom Perineal Healing	WITCH HAZEL	Fridababy, LLC	6a58e2a8-c4d5-4078-b5f4-28504de1f020	2024-12-30	Warnings	Exact identifier application number: M015
frida mom Labor and Delivery Plus Postpartum Recovery	WITCH HAZEL	Fridababy, LLC	4b5fc312-4c8c-4396-a70c-b1ed129038c7	2024-12-30	Warnings	Exact identifier application number: M015
Tucks Triple Relief Hemorrhoidal	WHITE PETROLATUM, GLYCERIN, PRAMOXINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Blistex Inc.	bf892e90-2d9b-4fa0-8ee4-8a2736be6c30	2024-12-24	Warnings	Exact identifier application number: M015
BLISS GVS HEMORRHOIDAL	PHENYLEPHRINE HCL	Bliss GVS Pharma Limited	fceea303-2ea0-10e9-e053-6294a90a5492	2024-12-21	Warnings	Exact identifier application number: M015
Dibucaine	DIBUCAINE 1%	Geri-Care Pharmaceuticals, Corp	afe88610-5cac-960e-e053-2a95a90a7ba4	2024-12-20	Warnings	Exact identifier application number: M015
Hemorroidal Cooling gel	PHENYLEPHRINE, WITCH HAZEL	Pharmacy Value Alliance, LLC	7276aab8-0297-2a55-e053-2a91aa0a8d21	2024-12-20	Warnings	Exact identifier application number: M015
HemorrhoidalOintment	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI	Pharmacy Value Alliance, LLC	3803a61b-308a-14a9-e054-00144ff88e88	2024-12-20	Warnings	Exact identifier application number: M015
Bliss GVS Hemorrhoidal	HARD FAT, PHENYLEPHRINE HCL	Bliss GVS Pharma Limited	88c49f6c-2a48-2dae-e053-2a95a90af20a	2024-12-19	Warnings	Exact identifier application number: M015
Rectal Care Cream Revivol	LIDOCAINE 5%	Derma Care Research Labs	a1c75161-f84a-e996-e053-2a95a90ac0c5	2024-12-19	Warnings	Exact identifier application number: M015
DCH Numbing Relief	LIDOCAINE 5%	Derma Care Research Labs, LLC	ffd70a31-7d0c-d2d0-e053-6394a90a8674	2024-12-19	Warnings	Exact identifier application number: M015
DCH Hemorrhoidal	GLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%	Derma Care Research Labs, LLC	0050701f-4393-3f01-e063-6394a90a4e0e	2024-12-19	Warnings	Exact identifier application number: M015
Moshe Numbing Hemorrhoidal	LIDOCAINE 5%	Derma Care Research Labs	fbd5b488-1921-e9b7-e053-6294a90aba70	2024-12-19	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