Leader Calamine Plus

Product NDC: 70000-0400
11-digit product format: 700000400
Labeler code: 70000
Product ID: 70000-0400_0d1994b2-3c1b-6322-e063-6394a90a1b6c
Type: HUMAN OTC DRUG
Nonproprietary name: zinc oxide lotion
Dosage form: LOTION
Route: TOPICAL
Labeler: Cardinal Health, 110 dba Leader
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-02-15
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: Leader Calamine Plus
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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1234532	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
81f29789-f794-1e64-e053-2a91aa0ac85e	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
70000-0400-1	Leader Calamine Plus	177 mL in 1 CONTAINER	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
70000-0400-1	ML - Milliliter	70000-0400	02eb5c5d-1078-4172-acc3-41965dc92c4e	1	2019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70000-0400	LEADER CALAMINE PLUS (ZINC OXIDE LOTION) LOTION [CARDINAL HEALTH, 110 DBA LEADER]	5	Current NDC, Legacy NDC, 1 package rows	20231223_81f29789-f794-1e64-e053-2a91aa0ac85e.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 64 of 68 · 1,346 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sunmark Witch Hazel	WITCH HAZEL	Strategic Sourcing Services LLC	08c00c1a-7ec8-4624-9db0-a0e8430cd126	2023-12-19	Warnings	Exact identifier application number: M016
Sunmark Caldyphen Clear	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Strategic Sourcing Services LLC	329cd4ef-b699-46ff-a5d6-907f7c327c03	2023-12-19	Warnings	Exact identifier application number: M016
DDM Calaclear	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Discount Drug Mart	5d536077-b5c6-29b8-e053-2a91aa0a9ae1	2023-12-19	Warnings	Exact identifier application number: M016
Sunmark Phenolated Calamine	CALAMINE AND ZINC OXIDE AND PHENOL	Strategic Sourcing Services LLC	8e68efc4-4c95-41c0-9fed-32297b1b2edc	2023-12-19	Warnings	Exact identifier application number: M016
Calm and Heal Melting Balm	ALLANTOIN	The Honest Company, Inc.	b08a1bd6-986d-9520-e053-2995a90a865e	2023-12-19	Warnings	Exact identifier application number: M016
TopCare Calagesic	CALAMINE AND PRAMOXINE HYDROCHLORIDE LOTION	TOPCO ASSOCIATES LLC	8dced3ea-147b-3d46-e053-2a95a90aa1c0	2023-12-18	Warnings	Exact identifier application number: M016
TopCare Calamine	CALAMINE 8% AND ZINC OXIDE 8% LOTION	TOPCO ASSOCIATES LLC	8dcf134e-0427-0c43-e053-2995a90a7c26	2023-12-18	Warnings	Exact identifier application number: M016
HEB Calaclear	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	H E B	5d576794-88d1-484a-e053-2991aa0aa479	2023-12-18	Warnings	Exact identifier application number: M016
Publix Calamine Medicated	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Publix	5d6ba4cf-f2cb-0ecb-e053-2991aa0a5673	2023-12-18	Warnings	Exact identifier application number: M016
TopCare Calaclear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTION	TOPCO ASSOCIATES LLC	8dce8817-b905-4064-e053-2995a90a071e	2023-12-18	Warnings	Exact identifier application number: M016
Assured Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Greenbriar International	9d378cc5-9af0-1389-e053-2995a90a0b96	2023-12-18	Warnings	Exact identifier application number: M016
HEB Calagesic	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	H E B	5d579680-6bcb-1161-e053-2991aa0aead1	2023-12-18	Warnings	Exact identifier application number: M016
Publix Clear Anti-Itch	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Publix	5d6b905f-ed30-1ab7-e053-2a91aa0a816b	2023-12-18	Warnings	Exact identifier application number: M016
Humco Calaclear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE	Humco Holding Group, Inc.	5fca3a73-6d66-496b-bd33-6e044f9039bc	2023-12-15	Warnings	Exact identifier application number: M016
Calamine Phenolated Topical Suspension	CALAMINE AND ZINC OXIDE AND PHENOL	Humco Holding Group, Inc	a3816729-be2b-4b4f-a609-953576cd2e3b	2023-12-15	Warnings	Exact identifier application number: M016
Humco Mineral Oil Light	MINERAL OIL	Humco Holding Group, Inc.	753f35c3-1420-4817-ba63-b737a9c99a1d	2023-12-15	Warnings	Exact identifier application number: M016
Humco Witch Hazel	WITCH HAZEL	Humco Holding Group, Inc.	3cf07016-a129-49ca-8fad-b67dda5aa009	2023-12-15	Warnings	Exact identifier application number: M016
Rite Aid Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Rite Aid Corporation	5df71189-9b36-9dee-e053-2a91aa0a9e49	2023-12-15	Warnings	Exact identifier application number: M016
GNP Witch Hazel	WITCH HAZEL	Amerisource Bergen	45ac839d-215d-4c5f-8ae5-5e111d170061	2023-12-14	Warnings	Exact identifier application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 Skin Protectant	GLYCERIN	L'Oreal USA Products Inc	32eaaaab-41bd-4efe-a71d-92e3a702c1e5	2023-12-11	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
1234532	calamine 8 % / pramoxine HCl 1 % Topical Lotion	PSN	81f29789-f794-1e64-e053-2a91aa0ac85e	5
1234532	calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion	SCD	81f29789-f794-1e64-e053-2a91aa0ac85e	5
1234532	calamine 8 % / pramoxine hydrochloride 1 % Topical Lotion	SY	81f29789-f794-1e64-e053-2a91aa0ac85e	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70000-0400-1	70000040001	177 mL in 1 CONTAINER (70000-0400-1)	177 ml	2019-02-15	0000-00-00	No	No	Current