Calamine

Product NDC: 83324-053
11-digit product format: 833240053
Labeler code: 83324
Product ID: 83324-053_4bcf72e3-68ba-8e7d-e063-6294a90a7536
Type: HUMAN OTC DRUG
Nonproprietary name: Calamine, Pramoxine HCl
Dosage form: LOTION
Route: TOPICAL
Labeler: Chain Drug Marketing Association
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-02-26
Substance: FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE
Active strength: 80; 10 mg/mL; mg/mL
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: Calamine
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FERRIC OXIDE RED	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
1K09F3G675	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
6c848b98-f01c-40f2-a9aa-2af76cb370c8	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
83324-053-06	Calamine	177 mL in 1 BOTTLE, PLASTIC	LOTION	177		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
83324-053-06	ML - Milliliter	83324-053	533b1be6-53af-49e3-a19c-e445287293c6	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83324-053	CALAMINE (CALAMINE, PRAMOXINE HCL) LOTION [CDMA]	2	Current NDC, 1 package rows	20250228_6c848b98-f01c-40f2-a9aa-2af76cb370c8.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 54 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Find Your Happy Place	AFTER THE RAIN HAND SANITIZER	Conopco Inc. d/b/a/ Unilever	ba0d27fb-f72f-5e87-e053-2a95a90af7e0	2024-11-07	Warnings	Exact identifier application number: M016
Love Beauty and Planet	BELOVED CATCUS FLOWER AND BASIL HAND SANITIZER	Conopco Inc. d/b/a/ Unilever	ba47599c-3e11-cec3-e053-2a95a90aef7b	2024-11-07	Warnings	Exact identifier application number: M016
Find Your Happy Place	WRAPPED IN YOUR ARMS HAND SANITIZER	Conopco Inc. d/b/a/ Unilever	ba0ef938-da18-3b9c-e053-2995a90acb72	2024-11-07	Warnings	Exact identifier application number: M016
Find Your Happy Place	SUNKISSED OCEAN WAVES HAND SANITIZER	Conopco Inc. d/b/a/ Unilever	ba0db6a3-222a-093f-e053-2a95a90ac88a	2024-11-07	Warnings	Exact identifier application number: M016
Find Your Happy Place	LAZY WEEKENDS HAND SANITIZER	Conopco Inc. d/b/a/ Unilever	ba0f4571-e752-d925-e053-2995a90afd3a	2024-11-07	Warnings	Exact identifier application number: M016
Love Beauty and Planet	BELOVED GREEN CLAY AND EUCALYPTUS HAND SANITIZER	Conopco Inc. d/b/a/ Unilever	ba48b351-0d7f-5a41-e053-2a95a90a348c	2024-11-07	Warnings	Exact identifier application number: M016
Love Beauty and Planet	BELOVED COCONUT AND WARM VANILLA HAND SANITIZER	Conopco Inc. d/b/a/ Unilever	ba0ffbf9-7dd0-f685-e053-2995a90a0be0	2024-11-07	Warnings	Exact identifier application number: M016
Love Beauty and Planet	BELOVED PATCHOULI AND ORANGE FLOWER HAND SANITIZER	Conopco Inc. d/b/a/ Unilever	ba49e27b-1ade-a75a-e053-2a95a90a1843	2024-11-07	Warnings	Exact identifier application number: M016
Love Beauty and Planet	BELOVED CHERRY BLOSSOM AND TEA ROSE HAND SANITIZER	Conopco Inc. d/b/a/ Unilever	ba4979a3-ae30-42e4-e053-2995a90abfe7	2024-11-07	Warnings	Exact identifier application number: M016
Find Your Happy Place	SWEET TREATS HAND SANITIZER	Conopco Inc. d/b/a/ Unilever	ba0fa3cb-8c25-7511-e053-2995a90a4287	2024-11-07	Warnings	Exact identifier application number: M016
Love Beauty and Planet	BELOVED LAVENDER AND HYSSOP HAND SANITIZER	Conopco Inc. d/b/a/ Unilever	ba484531-ef7b-17ed-e053-2995a90a50b3	2024-11-07	Warnings	Exact identifier application number: M016
Love Beauty and Planet	BELOVED GRAPEFRUIT AND RED GINGER HAND SANITIZER	Conopco Inc. d/b/a/ Unilever	ba4a573d-def4-a735-e053-2995a90a4f29	2024-11-07	Warnings	Exact identifier application number: M016
Dove	HAND SANITIZER LAVENDER	Conopco Inc. d/b/a/ Unilever	ddcb0871-9903-125f-e053-2a95a90a75de	2024-11-07	Warnings	Exact identifier application number: M016
Dove	MOISTURIZING HAND SANITIZER WIPES SHEA BUTTER AND WARM VANILLA SCENT	Conopco Inc. d/b/a/ Unilever	debc5983-e8bc-c6d5-e053-2995a90af774	2024-11-07	Warnings	Exact identifier application number: M016
Baby Dove	8H MOISTURIZATION HAND SANITIZER FRAGRANCE FREE	Conopco Inc. d/b/a/ Unilever	df734b51-33ae-d6b7-e053-2995a90a08cc	2024-11-07	Warnings	Exact identifier application number: M016
Dove	HAND SANITIZER WIPES SHEA BUTTER AND WARM VANILLA SCENT	Conopco Inc. d/b/a/ Unilever	df73e518-caec-a73b-e053-2995a90a69f5	2024-11-07	Warnings	Exact identifier application number: M016
Dove	HAND SANITIZER DEEP MOISTURE	Conopco Inc. d/b/a/ Unilever	ddca7c55-0a7e-cea6-e053-2995a90ace5a	2024-11-07	Warnings	Exact identifier application number: M016
Dove	HAND SANITIZER SHEA BUTTER	Conopco Inc. d/b/a/ Unilever	ddcad36b-1909-3bbb-e053-2995a90a295a	2024-11-07	Warnings	Exact identifier application number: M016
Dove	NOURISHING HAND SANITIZER SENSITIVE SKIN 8HR MOISTURIZATION	Conopco Inc. d/b/a/ Unilever	ddcbab1c-7af9-2656-e053-2995a90ad07a	2024-11-07	Warnings	Exact identifier application number: M016
Dove	HAND SANITIZER WIPES ALOE AND EUCALYPTUS SCENT	Conopco Inc. d/b/a/ Unilever	df74d901-c86c-ed71-e053-2995a90a39c2	2024-11-07	Warnings	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1K09F3G675	FERRIC OXIDE RED	1309-37-1	FERRIC OXIDE RED
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	6c848b98-f01c-40f2-a9aa-2af76cb370c8	3
1234532	calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion	SCD	6c848b98-f01c-40f2-a9aa-2af76cb370c8	3
1234532	calamine 8 % / pramoxine hydrochloride 1 % Topical Lotion	SY	6c848b98-f01c-40f2-a9aa-2af76cb370c8	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
83324-053-06	83324005306	177 mL in 1 BOTTLE, PLASTIC (83324-053-06)	177 ml	2025-02-26	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Quality Choice 336.003/336AG Medicated Calamine Lotion	Chain Drug Marketing Association \| Nice-Pak Products, LLC	2026-02-27	HUMAN OTC DRUG LABEL	3