Quality Choice Calamine

Product NDC: 63868-317
11-digit product format: 638680317
Labeler code: 63868
Product ID: 63868-317_0cf4bfe6-384e-e836-e063-6394a90ab8c3
Type: HUMAN OTC DRUG
Nonproprietary name: Calamine 8% and Zinc Oxide 8%
Dosage form: LOTION
Route: TOPICAL
Labeler: Chain Drug Market Association
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1998-03-25
Substance: ZINC OXIDE
Active strength: 160 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: Quality Choice Calamine
Listing expiration: 2027-12-31

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
62fe653f-e861-472b-b193-4fdd9d25de8d	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
63868-317-06	Quality Choice Calamine	177 mL in 1 BOTTLE, PLASTIC	LOTION	177		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63868-317-06	ML - Milliliter	63868-317	7bd5ebc8-0850-45dc-ae0b-ff9b628d3ca5	1	2014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Zinc Oxide	ACTIVE INGREDIENT	SOI2LOH54Z	QUALITY CHOICE CALAMINE (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [CHAIN DRUG MARKET ASSOCIATION]	1
ZINC CATION	ACTIVE MOIETY	13S1S8SF37	QUALITY CHOICE CALAMINE (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [CHAIN DRUG MARKET ASSOCIATION]	1
CALCIUM HYDROXIDE	INACTIVE INGREDIENT	PF5DZW74VN	QUALITY CHOICE CALAMINE (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [CHAIN DRUG MARKET ASSOCIATION]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	QUALITY CHOICE CALAMINE (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [CHAIN DRUG MARKET ASSOCIATION]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	QUALITY CHOICE CALAMINE (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [CHAIN DRUG MARKET ASSOCIATION]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63868-317	QUALITY CHOICE CALAMINE (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [CHAIN DRUG MARKET ASSOCIATION]	6	Current NDC, Legacy NDC, 1 package rows	20231221_62fe653f-e861-472b-b193-4fdd9d25de8d.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 26 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DE LA CRUZ DIAPER RASH	ALLANTOIN, PETROLATUM, AND ZINC OXIDE	DLC Laboratories, Inc.	5949aa0f-a7cb-453c-81fd-9fa24653a452	2026-01-07	Warnings	Exact identifier application number: M016
Thera Wise Natural Hemorrhoidal	WITCH HAZEL	Derma Wise Skin Care Ltd.	a29fb680-cfc8-4a7b-9970-563fa0e2bed6	2026-01-06	Warnings	Exact identifier application number: M016
Sky and Sol SPF25 Lip Balm	SKY AND SOL SPF25 LIP BALM	Guangzhou Fantesy Biotechnology Co.,Ltd	1f37c0c3-6443-60a3-e063-6394a90a596f	2026-01-05	Warnings	Exact identifier application number: M016
Remedy Essentials	WHITE PETROLATUM,ZINC OXIDE	Medline Industries, LP	42a033d6-782b-2d7f-e054-00144ff8d46c	2026-01-05	Warnings	Exact identifier application number: M016
BUNUSS Estriol Face	ESTRIOL	Jiashen International Trade Limited	478b5690-038a-ba1c-e063-6394a90a3ad6	2026-01-04	Warnings	Exact identifier application number: M016
Skin Protectant for Babies and kids	SKIN PROTECTANT OINTMENT	Neilmed Pharmaceuticals Inc.	448b70db-ca81-db7b-e063-6294a90a5f0d	2026-01-02	Warnings	Exact identifier application number: M016
Puriya Eczema Cream	COLLOIDAL OATMEAL	IPC Republic, Inc.	24ac044e-13fa-5ff6-e063-6294a90a9985	2026-01-01	Warnings	Exact identifier application number: M016
Scarzen	DIMETHICONE	Village Pharma LLC	1550f4e5-22e2-491f-8184-de65da7234e6	2026-01-01	Warnings	Exact identifier application number: M016
NUVALU 100 PURE PETROLEUM	WHITE PETROLATUM	JC SALES	48f74b99-7ead-b0d0-e063-6394a90a4929	2026-01-01	Warnings	Exact identifier application number: M016
NUVALU PETROLEUM BABY FRESH SCENT	WHITE PETROLATUM	JC SALES	48f79c2a-b314-169f-e063-6294a90a576e	2026-01-01	Warnings	Exact identifier application number: M016
NUVALU PETROLEUM BABY FRESH SCENT	WHITE PETROLATUM	JC SALES	490ac0a6-eac0-a74f-e063-6394a90a84ed	2026-01-01	Warnings	Exact identifier application number: M016
NUVALU PETROLEUM COCOA BUTTER	WHITE PETROLATUM	JC SALES	490af001-c78c-e2d2-e063-6394a90abdb0	2026-01-01	Warnings	Exact identifier application number: M016
NUVALU 100 PURE PETROLEUM	WHITE PETROLATUM	Ningbo Liyuan Daily Chemical Products Co., Ltd.	4946ac1a-f475-fbb1-e063-6394a90a30bc	2026-01-01	Warnings	Exact identifier application number: M016
NUVALU PETROLEUM BABY FRESH SCENT	WHITE PETROLATUM	Ningbo Liyuan Daily Chemical Products Co., Ltd.	4946d1b7-ae1b-1e73-e063-6394a90a1ed2	2026-01-01	Warnings	Exact identifier application number: M016
NUVALU PETROLEUM BABY FRESH SCENT	WHITE PETROLATUM	Ningbo Liyuan Daily Chemical Products Co., Ltd.	49471d77-303a-8536-e063-6394a90aea51	2026-01-01	Warnings	Exact identifier application number: M016
NUVALU PETROLEUM COCOA BUTTER	WHITE PETROLATUM	Ningbo Liyuan Daily Chemical Products Co., Ltd.	49472319-09d1-7c4f-e063-6294a90a26a7	2026-01-01	Warnings	Exact identifier application number: M016
Olay Ultimate Sensitive Colloidal Oatmeal Skin Protectant Moisturizer Fragrance Free	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	1fa6282a-172e-f5c8-e063-6294a90a4fb1	2025-12-31	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Vanilla Latte	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	27713ae6-b428-e0d7-e063-6394a90a7a89	2025-12-31	Warnings	Exact identifier application number: M016
Eucerin Eczema Relief Body	OATMEAL	Beiersdorf Inc	9895f3c3-b00b-462c-ace0-696d688e2e04	2025-12-31	Warnings	Exact identifier application number: M016
Eucerin Eczema Relief Flare Up Treatment	OATMEAL	Beiersdorf Inc	a9ea4832-3211-40b2-accf-90ace7b9e279	2025-12-31	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	62fe653f-e861-472b-b193-4fdd9d25de8d	6
617954	calamine 80 MG/ML / zinc oxide 80 MG/ML Topical Lotion	SCD	62fe653f-e861-472b-b193-4fdd9d25de8d	6
617954	calamine 8 % / zinc oxide 8 % Topical Lotion	SY	62fe653f-e861-472b-b193-4fdd9d25de8d	6
617954	Calamine 80 MG/ML / ZNO 80 MG/ML Topical Lotion	SY	62fe653f-e861-472b-b193-4fdd9d25de8d	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63868-317-06	63868031706	177 mL in 1 BOTTLE, PLASTIC (63868-317-06)	177 ml	2017-12-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Quality Choice Calamine Lotion, USP	Chain Drug Market Association \| Pharma Nobis, LLC	2023-12-20	HUMAN OTC DRUG LABEL	6