Sunmark Caldiphen

Product NDC: 49348-337
11-digit product format: 493480337
Labeler code: 49348
Product ID: 49348-337_0ec0504c-907b-15fa-e063-6294a90a871f
Type: HUMAN OTC DRUG
Nonproprietary name: Calamine and Pramoxine Hydrochloride
Dosage form: LOTION
Route: TOPICAL
Labeler: Strategic Sourcing Services
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1998-03-25
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: 2026-12-31
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: Sunmark Caldiphen
Listing expiration: 2026-12-31

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
4f4d4c54-64b5-4e20-bed0-c7fb470b8434	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
49348-337-36	Sunmark Caldiphen	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
49348-337-36	ML - Milliliter	49348-337	842b75c5-cc64-4250-a67c-ca1427b15452	1	2014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PRAMOXINE HYDROCHLORIDE	ACTIVE INGREDIENT	88AYB867L5	SUNMARK CALDIPHEN (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [MCKESSON]	1
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	SUNMARK CALDIPHEN (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [MCKESSON]	1
PRAMOXINE	ACTIVE MOIETY	068X84E056	SUNMARK CALDIPHEN (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [MCKESSON]	1
ZINC CATION	ACTIVE MOIETY	13S1S8SF37	SUNMARK CALDIPHEN (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [MCKESSON]	1
CAMPHOR (NATURAL)	INACTIVE INGREDIENT	N20HL7Q941	SUNMARK CALDIPHEN (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [MCKESSON]	1
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	SUNMARK CALDIPHEN (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [MCKESSON]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	SUNMARK CALDIPHEN (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [MCKESSON]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	SUNMARK CALDIPHEN (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [MCKESSON]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	SUNMARK CALDIPHEN (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [MCKESSON]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	SUNMARK CALDIPHEN (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [MCKESSON]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	SUNMARK CALDIPHEN (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [MCKESSON]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	SUNMARK CALDIPHEN (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [MCKESSON]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49348-337	SUNMARK CALDIPHEN (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [STRATEGIC SOURCING SERVICES]	5	Current NDC, Legacy NDC, 1 package rows	20240113_4f4d4c54-64b5-4e20-bed0-c7fb470b8434.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
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
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	4f4d4c54-64b5-4e20-bed0-c7fb470b8434	5
1234532	calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion	SCD	4f4d4c54-64b5-4e20-bed0-c7fb470b8434	5
1234532	calamine 8 % / pramoxine hydrochloride 1 % Topical Lotion	SY	4f4d4c54-64b5-4e20-bed0-c7fb470b8434	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49348-337-36	49348033736	177 mL in 1 BOTTLE, PLASTIC (49348-337-36)	177 ml	2014-04-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sunmark Caldyphen Lotion	Strategic Sourcing Services \| Pharma Nobis, LLC	2024-01-12	HUMAN OTC DRUG LABEL	5