GNP Calamine Topical Suspension

Product NDC: 24385-413
11-digit product format: 243850413
Labeler code: 24385
Product ID: 24385-413_53740c50-0f6a-f5ea-e063-6294a90a48ea
Type: HUMAN OTC DRUG
Nonproprietary name: Calamine 8% and Zinc Oxide 8%
Dosage form: LOTION
Route: TOPICAL
Labeler: Amerisource Bergen
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2008-01-01
Marketing end: 2029-11-01
Substance: ZINC OXIDE
Active strength: 160 mg/mL
Pharmacologic classes: Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag: No
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: GNP Calamine Topical Suspension

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	160 mg/mL

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
617954	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
777b0e66-1bce-4483-9dad-c46796fd6f23	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
24385-413-96	GNP Calamine Topical Suspension	177 mL in 1 BOTTLE, PLASTIC	LOTION	177		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
24385-413-96	ML - Milliliter	24385-413	9477c0b9-62d7-4cf7-8602-b1fb4ff448f9	1	2013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	GNP CALAMINE TOPICAL SUSPENSION (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [AMERISOURCE BERGEN]	1
ZINC CATION	ACTIVE MOIETY	13S1S8SF37	GNP CALAMINE TOPICAL SUSPENSION (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [AMERISOURCE BERGEN]	1
BENTONITE	INACTIVE INGREDIENT	A3N5ZCN45C	GNP CALAMINE TOPICAL SUSPENSION (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [AMERISOURCE BERGEN]	1
CALCIUM HYDRIDE	INACTIVE INGREDIENT	WY779SQ0XW	GNP CALAMINE TOPICAL SUSPENSION (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [AMERISOURCE BERGEN]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	GNP CALAMINE TOPICAL SUSPENSION (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [AMERISOURCE BERGEN]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	GNP CALAMINE TOPICAL SUSPENSION (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [AMERISOURCE BERGEN]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
24385-413	GNP CALAMINE TOPICAL SUSPENSION (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [AMERISOURCE BERGEN]	5	Current NDC, Legacy NDC, 1 package rows	20231215_777b0e66-1bce-4483-9dad-c46796fd6f23.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 13 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Colloidal oatmeal	COLLOIDAL OATMEAL	CVS Pharmacy, Inc.	4a43b1a2-2156-e490-e063-6294a90a6f84	2026-04-07	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	CALAMINE 8%, ZINC OXIDE 8%	Farmacias De Similares TX LLC	4ecd0add-11c9-cf3b-e063-6394a90adff6	2026-04-06	Warnings	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	CVS Pharmacy, Inc.	4dc08832-e610-4e62-a6af-cadaa339e39e	2026-04-06	Warnings, Adverse reactions	Exact identifier application number: M016
Witch Hazel	WITCH HAZEL SPRAY	CVS Pharmacy	53db78a8-eb2d-431b-84c1-73e99bb9d3d1	2026-04-06	Warnings	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	Amazon.com Services LLC	616ef87d-1518-46aa-8e12-9a1b678d4980	2026-04-06	Warnings, Adverse reactions	Exact identifier application number: M016
Stabilizing Repair Serum	OATMEAL	Dermalogica, LLC.	86b7b230-5424-46d3-8058-656f5172fc70	2026-04-02	Warnings	Exact identifier application number: M016
calamine	CALAMINE AND ZINC OXIDE	STRATEGIC SOURCING SERVICES	4e6a7bdf-4ef1-65e2-e063-6394a90ae124	2026-04-01	Warnings	Exact identifier application number: M016
Aveeno Eczema Therapy Rescue Relief Treatment Gel Cream	COLLOIDAL OATMEAL	Kenvue Brands LLC	4e4e1797-26e6-a67b-e063-6294a90af438	2026-03-31	Warnings	Exact identifier application number: M016
Target Advanced Scar Gel	ADVANCED SCAR GEL	Target Corporation	86c215fe-aad4-45d1-bdb7-cde00a115c5c	2026-03-31	Warnings	Exact identifier application number: M016
Zinc oxide, Dimethicone	ZINC OXIDE, DIMETHICONE	Walmart Inc.	4cbf9492-33cd-e6d4-e063-6294a90ab001	2026-03-31	Warnings, Adverse reactions	Exact identifier application number: M016
Critic-Aid Clear	PETROLATUM	Coloplast Corp	a92c18f7-52b2-43e4-bae3-2bab9de22671	2026-03-31	Warnings	Exact identifier application number: M016
3M Cavilon Durable Barrier	DIMETHICONE	Solventum US LLC	f3f8be33-4ad2-4f5f-ac94-ddfbe0280b83	2026-03-31	Warnings	Exact identifier application number: M016
XIMONTH Foot Sanitizer	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	4e38d24d-3745-c121-e063-6394a90abbb5	2026-03-30	Warnings	Exact identifier application number: M016
Dynashield	ZINC OXIDE	Dynarex Corporation	59fd865c-b81d-43ad-8fa0-c37ca0557769	2026-03-30	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant	COLLOIDAL OATMEAL	Port Jervis Laboratories, Inc	4e43b65c-d5bb-f228-e063-6294a90ad08d	2026-03-30	Warnings	Exact identifier application number: M016
ChapStick Classic Original	SKIN PROTECTANT LIP BALM	Suave Brands Co., LLC	4275956d-275a-4e31-e063-6394a90a78d3	2026-03-30	Warnings	Exact identifier application number: M016
ChapStick Classic Cherry	SKIN PROTECTANT LIP BALM	Suave Brands Co., LLC	42762471-e5cd-505e-e063-6294a90afb7d	2026-03-30	Warnings	Exact identifier application number: M016
ChapStick Classic Variety Cherry-Strawberry-Spearmint	SKIN PROTECTANT LIP BALM	Suave Brands Co., LLC	450e46d2-de86-e5fa-e063-6294a90ac6ff	2026-03-30	Warnings	Exact identifier application number: M016
ChapStick Classic Original	SKIN PROTECTANT LIP BALM	Suave Brands Co., LLC	4512220a-9fc2-8816-e063-6394a90a9d15	2026-03-30	Warnings	Exact identifier application number: M016
ChapStick Classic Original Military	SKIN PROTECTANT LIP BALM	Suave Brands Co., LLC	45136b7e-136b-0283-e063-6394a90a599a	2026-03-30	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
617954	calamine 8 % / zinc oxide 8 % Topical Lotion	PSN	777b0e66-1bce-4483-9dad-c46796fd6f23	5
617954	calamine 80 MG/ML / zinc oxide 80 MG/ML Topical Lotion	SCD	777b0e66-1bce-4483-9dad-c46796fd6f23	5
617954	calamine 8 % / zinc oxide 8 % Topical Lotion	SY	777b0e66-1bce-4483-9dad-c46796fd6f23	5
617954	Calamine 80 MG/ML / ZNO 80 MG/ML Topical Lotion	SY	777b0e66-1bce-4483-9dad-c46796fd6f23	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
24385-413-96	24385041396	177 mL in 1 BOTTLE, PLASTIC (24385-413-96)	177 ml	2017-11-16	2029-11-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GNP Calamine Topical Suspension	Amerisource Bergen \| Pharma Nobis, LLC	2026-06-04	HUMAN OTC DRUG LABEL	6