Humco Calaclear

Product NDC: 0395-0400
11-digit product format: 003950400
Labeler code: 0395
Product ID: 0395-0400_0c929258-b193-bc2f-e063-6394a90a8e47
Type: HUMAN OTC DRUG
Nonproprietary name: Pramoxine Hydrochloride and Zinc Acetate
Dosage form: LOTION
Route: TOPICAL
Labeler: Humco Holding Group, Inc.
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1998-03-25
Substance: PRAMOXINE HYDROCHLORIDE; ZINC ACETATE
Active strength: 10; 1 mg/mL; mg/mL
Pharmacologic classes: Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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: Humco Calaclear
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PRAMOXINE HYDROCHLORIDE	10 mg/mL
ZINC ACETATE	1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
88AYB867L5	Internal UNII lookup
FM5526K07A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1234546	Internal RxNorm lookup
1248193	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
5fca3a73-6d66-496b-bd33-6e044f9039bc	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0395-0400-96	Humco Calaclear	177 mL in 1 BOTTLE, PLASTIC	LOTION	177		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0395-0400-96	ML - Milliliter	0395-0400	5d47f9f0-f8d2-4b5e-a5bf-5e5ef8a7de71	1	2014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PRAMOXINE HYDROCHLORIDE	ACTIVE INGREDIENT	88AYB867L5	HUMCO CALAGESIC (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.]	1
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	HUMCO CALAGESIC (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.]	1
PRAMOXINE	ACTIVE MOIETY	068X84E056	HUMCO CALAGESIC (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.]	1
ZINC CATION	ACTIVE MOIETY	13S1S8SF37	HUMCO CALAGESIC (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	HUMCO CALAGESIC (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.]	1
CAMPHOR (NATURAL)	INACTIVE INGREDIENT	N20HL7Q941	HUMCO CALAGESIC (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.]	1
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	HUMCO CALAGESIC (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	HUMCO CALAGESIC (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HUMCO CALAGESIC (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	HUMCO CALAGESIC (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HUMCO CALAGESIC (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	HUMCO CALAGESIC (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	HUMCO CALAGESIC (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0395-0400	HUMCO CALACLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [HUMCO HOLDING GROUP, INC.]	7	Current NDC, Legacy NDC, 1 package rows	20231216_5fca3a73-6d66-496b-bd33-6e044f9039bc.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 61 of 68 · 1,346 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chapstick Total Hydration Moisture Tint Peachy Keen	ZINC OXIDE	Haleon US Holdings LLC	ef206fe7-2659-41dc-b117-380af704999b	2024-03-22	Warnings	Exact identifier application number: M016
Chapstick Total Hydration Moisture Tint Pretty in Pink	ZINC OXIDE	Haleon US Holdings LLC	e686ce23-57bc-4026-be62-d46d90ded442	2024-03-22	Warnings	Exact identifier application number: M016
Chapstick Total Hydration Moisture Tint Very Berry	ZINC OXIDE	Haleon US Holdings LLC	59023150-65ef-4427-9045-0e64b100cbab	2024-03-22	Warnings	Exact identifier application number: M016
Chapstick Moisturizer Cool Mint	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUM	Haleon US Holdings LLC	33497c07-ad6e-4c50-bc23-a55725b2eae1	2024-03-21	Warnings	Exact identifier application number: M016
Chapstick Moisturizer Original	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUM	Haleon US Holdings LLC	de250ae9-6e4a-46ca-bcc9-5bb07dbb70c5	2024-03-21	Warnings	Exact identifier application number: M016
ChapStick Classic Strawberry	WHITE PETROLATUM	Haleon US Holdings LLC	3a279496-74c5-4ab1-ba69-06ad4a4f67cf	2024-03-21	Warnings	Exact identifier application number: M016
Chapstick Moisturizer Cool Mint	AVOBENZONE, OCTINOXATE, AND WHITE PETROLATUM	Haleon US Holdings LLC	c1120c7a-1fa8-45a4-8bcf-35d9cc9f2c74	2024-03-21	Warnings	Exact identifier application number: M016
terrasil Diabetics Ulcer and Sore Relief Kit	ALLANTOIN	Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions	523b6598-8039-4116-b0f8-ba31d7d6ea9d	2024-03-20	Warnings	Exact identifier application number: M016
ChapStick Classic Cherry	WHITE PETROLATUM	Haleon US Holdings LLC	db041b1b-084a-4283-b6ba-4d4bcdc220b3	2024-03-19	Warnings	Exact identifier application number: M016
ChapStick Classic Original	WHITE PETROLATUM	Haleon US Holdings LLC	42fe0f4a-efb7-4e70-a359-db7dc2ac9905	2024-03-19	Warnings	Exact identifier application number: M016
ChapStick Classic Spearmint	WHITE PETROLATUM	Haleon US Holdings LLC	74354d8e-c265-4a27-9715-1a4c157ad890	2024-03-19	Warnings	Exact identifier application number: M016
Cetaphil Healing	PETROLATUM	Galderma Laboratories, L.P.	e996db17-bd4d-4b06-bb9a-983dbdec8022	2024-03-13	Warnings	Exact identifier application number: M016
Diaper Rash Cream 2oz	ZINC OXIDE	Rejoice International Corp.	130a06a7-3360-afed-e063-6294a90ac19f	2024-03-06	Warnings	Exact identifier application number: M016
mama bear DIAPER RASH Skin Protectant	LANOLIN AND PETROLATUM	AMAZON.COM SERVICES LLC	cda9ca47-b668-4a65-908d-80b9a6515bd7	2024-03-06	Warnings	Exact identifier application number: M016
Dermachange Scar	ALLANTOIN	Private Label Beauty and Wellness	12eed473-10d6-49c8-e063-6394a90afb63	2024-03-05	Warnings	Exact identifier application number: M016
XtraCare Creamy Petroleum Jelly Cocoa Butter Enriched	PETROLEUM	Rejoice International	580d76ee-ea89-426e-bd25-7a58481e9795	2024-02-28	Warnings	Exact identifier application number: M016
XtraCare Creamy Petroleum Jelly Vitamin E enriched	PETROLATUM	Rejoice International	2c382a50-93d2-4d28-b7a4-1702b20b7139	2024-02-28	Warnings	Exact identifier application number: M016
XtraCare Foaming Facial Cleanser	TRICLOSAN	Rejoice International	313fcd4a-8641-417e-bf0b-02359ad815fe	2024-02-28	Warnings	Exact identifier application number: M016
XtraCare Skin Relief Oatmeal Daily Moisturizing	DIMETHICONE	Rejoice International	5ae6d5d4-caff-4360-a0e7-7c8d7a9b5907	2024-02-28	Warnings	Exact identifier application number: M016
XtraCare with cooling action Oatmeal Skin Relief Calmin	DIMETHICONE	Rejoice International	29abd476-c32d-49f0-b283-30f4ba570ab4	2024-02-28	Warnings	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
88AYB867L5	PRAMOXINE HYDROCHLORIDE	637-58-1	PRAMOXINE HYDROCHLORIDE
FM5526K07A	ZINC ACETATE	5970-45-6	ZINC ACETATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1248193	CALACLEAR 1 % / 0.1 % Topical Lotion	PSN	5fca3a73-6d66-496b-bd33-6e044f9039bc	7
1234546	pramoxine HCl 1 % / zinc acetate 0.1 % Topical Lotion	PSN	5fca3a73-6d66-496b-bd33-6e044f9039bc	7
1248193	pramoxine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical Lotion [Calaclear]	SBD	5fca3a73-6d66-496b-bd33-6e044f9039bc	7
1234546	pramoxine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical Lotion	SCD	5fca3a73-6d66-496b-bd33-6e044f9039bc	7
1248193	Calaclear (pramoxine hydrochloride 1 % / zinc acetate 0.1 % ) Topical Lotion	SY	5fca3a73-6d66-496b-bd33-6e044f9039bc	7
1234546	pramoxine HCl 1 % / zinc acetate 0.1 % Topical Lotion	SY	5fca3a73-6d66-496b-bd33-6e044f9039bc	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0395-0400-96	00395040096	177 mL in 1 BOTTLE, PLASTIC (0395-0400-96)	177 ml	1998-03-25	0000-00-00	No	No	Current