Calamine

Product NDC: 46122-809
11-digit product format: 461220809
Labeler code: 46122
Product ID: 46122-809_498db13a-f81f-8a0a-e063-6294a90a814c
Type: HUMAN OTC DRUG
Nonproprietary name: Calamine
Dosage form: LOTION
Route: TOPICAL
Labeler: AMERISOURCE BERGEN
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-04-23
Substance: FERRIC OXIDE RED; ZINC OXIDE
Active strength: 80; 80 mg/100mL; mg/100mL
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/100mL
ZINC OXIDE	80 mg/100mL

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
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
90d9d908-57ea-4062-ade0-8a4888939c91	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
46122-809-29	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
46122-809-29	ML - Milliliter	46122-809	e9e2817b-7f70-4097-9317-8cba5b27c622	1	2025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46122-809	CALAMINE LOTION [AMERISOURCE BERGEN]	2	Current NDC, 1 package rows	20250426_90d9d908-57ea-4062-ade0-8a4888939c91.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 23 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pure petroleum	WHITE PETROLATUM	Rite Aid Corporation	f67be4cc-9983-4758-93c8-383919ec07ca	2026-01-30	Warnings, Adverse reactions	Exact identifier application number: M016
Advanced Healing	PETROLATUM	Rite Aid Corporation	0d535736-ba61-42eb-9112-c154295372a2	2026-01-30	Warnings, Adverse reactions	Exact identifier application number: M016
UNIVERSAL BABY FRESH SCENT PETROLEUM	WHITE PETROLEUM	Universal Distribution Center LLC	ec67a1ee-ad71-54f2-e053-2995a90a7690	2026-01-29	Warnings	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	7-Select	7e93df71-74bd-4d95-9a64-54756c7b234a	2026-01-29	Warnings, Adverse reactions	Exact identifier application number: M016
TheraCare Diabetic Foot Cream	DIMETHICONE, PETROLATUM	Veridian Healthcare	49132a75-4a16-cede-e063-6294a90a6217	2026-01-29	Warnings	Exact identifier application number: M016
TheraCare A and D	LANOLIN, PETROLATUM	Veridian Healthcare	1303aa33-2111-b36c-e063-6294a90af131	2026-01-29	Warnings	Exact identifier application number: M016
Zinc oxide	ZINC OXIDE	Aldi, Inc	d56782c1-b23c-47a9-82cb-d7dbb0ac7aa3	2026-01-29	Warnings, Adverse reactions	Exact identifier application number: M016
Advanced Healing	PETROLATUM	Aldi, Inc	94fea2f2-fea8-4923-afc6-36068bc2fef5	2026-01-29	Warnings, Adverse reactions	Exact identifier application number: M016
DAILY MOISTURIZING	DIMETHICONE LOTION	Aldi, Inc	4ad18f4a-e148-4bf5-a04b-4168fa48eeb2	2026-01-29	Warnings, Adverse reactions	Exact identifier application number: M016
Baby Eczema Therapy	COLLOIDAL OATMEAL	Aldi, Inc	79f498af-c207-4f85-bf1b-fb2ee8379fd8	2026-01-29	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	CALAMINE	AMERISOURCE BERGEN	90d9d908-57ea-4062-ade0-8a4888939c91	2026-01-29	Warnings, Adverse reactions	Exact identifier application number: M016 ndc (product): 46122-809
UNIVERSAL LAVENDER SCENT PETROLEUM	WHITE PETROLEUM	Universal Distribution Center LLC	066b1313-aed8-9436-e063-6294a90a2b11	2026-01-29	Warnings	Exact identifier application number: M016
Equate Scar Topical	ALLANTOIN	WalMart	cf511a02-355c-4286-82fa-6f0c4a244823	2026-01-29	Warnings	Exact identifier application number: M016
TriDerma Stubborn Diaper Rash Relief	ALLANTOIN, DIMETHICONE	Genuine Virgin Aloe Corporation	f8f3ae0b-aa55-4c2f-8823-54268524917b	2026-01-28	Warnings	Exact identifier application number: M016
Sunscreen SPF50	NON NANO ZINC OXIDE	SBS BILIMSEL BIO COZUMLER SANAYI VE TICARET ANONIM SIRKETI PINAR SUBESI	c5d52f13-a649-9579-e053-2a95a90a062c	2026-01-27	Warnings	Exact identifier application number: M016
Equate Chafing Gel	DIMETHICONE	Walmart Inc	06665504-040c-a806-e063-6294a90acedc	2026-01-27	Warnings	Exact identifier application number: M016
Body Oil for Stretch Marks	HELIANTHUS ANNUUS (SUNFLOWER) SEED 0IL ,TOCOPHEROL,ADANSONIA DIGITATA SEED 0IL,MORINGA OLEIFERA SEED 0IL,THEOBROMA CACAO (COCOA) SEED BUTTER,ECHIUM PLANTAGINEUM SEED OIL,SESAMUM INDICUM (SESAME) SEED 0IL	Dongguan Xiaogoubeige trading company Ltd.	496af9a1-7249-622f-e063-6394a90aa284	2026-01-27	Warnings	Exact identifier application number: M016
Herpecin L	ZINC OXIDE, DIMETHICONE	Focus Consumer Healthcare, LLC	488a29c3-dd97-af1a-e063-6394a90aba7f	2026-01-26	Warnings	Exact identifier application number: M016
XIMONTH Nail Nourishing Pen	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	49451717-e41c-8ae0-e063-6294a90a91ad	2026-01-26	Warnings	Exact identifier application number: M016
Kerasal Athletes Foot Rapid Symptom Relief Medicated Soak	ALUMINUM SULFATE TETRADECAHYDRATE AND CALCIUM ACETATE MONOHYDRATE	Advantice Health, LLC.	09a178c1-0eb1-43e5-bde8-fd27ed633d59	2026-01-26	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
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	90d9d908-57ea-4062-ade0-8a4888939c91	3
617954	calamine 80 MG/ML / zinc oxide 80 MG/ML Topical Lotion	SCD	90d9d908-57ea-4062-ade0-8a4888939c91	3
617954	calamine 8 % / zinc oxide 8 % Topical Lotion	SY	90d9d908-57ea-4062-ade0-8a4888939c91	3
617954	Calamine 80 MG/ML / ZNO 80 MG/ML Topical Lotion	SY	90d9d908-57ea-4062-ade0-8a4888939c91	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
46122-809-29	46122080929	177 mL in 1 BOTTLE, PLASTIC (46122-809-29)	177 ml	2025-04-23	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Good Neighbor Pharmacy 063.001/063AA Calamine Lotion	AMERISOURCE BERGEN \| Nice-Pak Products, LLC	2026-01-29	HUMAN OTC DRUG LABEL	3