Humco Calagesic

Product NDC: 82645-922
11-digit product format: 826450922
Labeler code: 82645
Product ID: 82645-922_0d6ccb8f-d9c0-28e6-e063-6294a90a8a87
Type: HUMAN OTC DRUG
Nonproprietary name: Calamine and Pramoxine Hydrochloride
Dosage form: LOTION
Route: TOPICAL
Labeler: Pharma Nobis, LLC
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1998-03-25
Substance: ZINC OXIDE; PRAMOXINE HYDROCHLORIDE
Active strength: 80; 10 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 Calagesic
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	80 mg/mL
PRAMOXINE HYDROCHLORIDE	10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SOI2LOH54Z	Internal UNII lookup
88AYB867L5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1234532	Internal RxNorm lookup
1234539	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
e42fb807-8cb4-ed25-e053-2995a90a6780	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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
82645-922-96	Humco Calagesic	177 mL in 1 BOTTLE, PLASTIC	LOTION	177		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82645-922	HUMCO CALAGESIC (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [PHARMA NOBIS, LLC]	2	Current NDC, Legacy NDC, 1 package rows	20231227_e42fb807-8cb4-ed25-e053-2995a90a6780.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 17 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clear Anti-Itch	PRAMOXINE HCL, ZINC ACETATE	Old East Main Co.	91df1434-bce6-4c6e-beee-cb5ec1cc8fff	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M016
Advanced Healing	PETROLATUM	Old East Main Co.	cf916191-1de2-4305-b783-9e074c1ad94b	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M016
Eczema Relief	COLLOIDAL OATMEAL	Old East Main Co.	b2dba027-c295-4a41-8d30-144904e1aa34	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M016
Baby Eczema Therapy	COLLOIDAL OATMEAL	Old East Main Co.	9720e2ad-1bcf-4023-8e92-22a962df3aad	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	FERRIC OXIDE RED	Chain Drug Marketing Association	86ff4875-9007-4b7b-8f46-16cbd475d4bb	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Clear Anti-Itch	PRAMOXINE HCL, ZINC ACETATE	Chain Drug Marketing Association	1ff6bd85-3658-47ea-b6ca-0eb5d8dbb693	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	CALAMINE, PRAMOXINE HCL	Chain Drug Marketing Association	6c848b98-f01c-40f2-a9aa-2af76cb370c8	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	The Kroger Co.	fcffbe1f-79b8-451a-9384-19533b81d8c8	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	The Kroger Co.	d2095c7b-61ca-40d3-bbf1-04bed4dd789c	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Daily Moisturizing	DIMETHICONE	The Kroger Co.	ea8b186c-82d5-4552-bcce-03e56023ea99	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash Cream	ZINC OXIDE	Smalls Brand LLC DBA Roe Wellness	4bd29285-29b4-5d57-e063-6294a90af481	2026-02-27	Warnings	Exact identifier application number: M016
Vitamin A D	LANOLIN, PETROLATUM	Walmart Inc.	5893801a-25e1-4750-a55b-d9cddd3f1284	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	Walmart Inc.	320bcbd3-9e91-437f-99c5-066f880a4b32	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Skin Protectant	PETROLATUM	Walmart Inc.	eb836922-f467-42ab-a6e7-b787d97e6c17	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Advanced Healing	PETROLATUM	Walmart Inc.	aa7dbf7f-50be-475b-8140-68be3fa93507	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
White Petrolatum	WHITE PETROLATUM	Walmart Inc.	176d7711-7c4f-4319-91af-0aba1260c412	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Soothing Moisturizing	COLLOIDAL OATMEAL	Walmart Inc.	2d813455-c268-4c6d-9952-eaf0e0007d90	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Rapid Repair Healing Cream	ALLANTOIN, DIMETHICONE	June Jacobs Labs LLC	186c13be-5e41-b9c9-e063-6294a90ad574	2026-02-26	Warnings	Exact identifier application number: M016
Lanashield	LANOLIN	Dynarex Corporation	94b277dc-6512-4d36-8485-8ea510097428	2026-02-26	Warnings	Exact identifier application number: M016
GLADSKIN ECZEMACT ECZEMA	COLLOIDAL OATMEAL	Micreos North America, Inc.	06f9af75-c5ff-d37b-e063-6394a90a4f6c	2026-02-25	Warnings	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE
88AYB867L5	PRAMOXINE HYDROCHLORIDE	637-58-1	PRAMOXINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1234539	CALAGESIC 8 % / 1 % Topical Lotion	PSN	e42fb807-8cb4-ed25-e053-2995a90a6780	2
1234532	calamine 8 % / pramoxine HCl 1 % Topical Lotion	PSN	e42fb807-8cb4-ed25-e053-2995a90a6780	2
1234539	calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion [Calagesic]	SBD	e42fb807-8cb4-ed25-e053-2995a90a6780	2
1234532	calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion	SCD	e42fb807-8cb4-ed25-e053-2995a90a6780	2
1234539	Calagesic (calamine 8 % / pramoxine hydrochloride 1 % ) Topical Lotion	SY	e42fb807-8cb4-ed25-e053-2995a90a6780	2
1234532	calamine 8 % / pramoxine hydrochloride 1 % Topical Lotion	SY	e42fb807-8cb4-ed25-e053-2995a90a6780	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
82645-922-96	82645092296	177 mL in 1 BOTTLE, PLASTIC (82645-922-96)	177 ml	2017-11-13	0000-00-00	No	No	Current