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: 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: 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 58 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
insect bite relief 01	MENTHOL	Cosmuses Cosmetics (Ningbo) Co., Ltd.	006e457d-bfcd-791a-e063-6294a90a8d66	2024-09-23	Warnings	Exact identifier application number: M016
dabur	ZINC OXIDE	Dabur India Limited	22cd1e7a-5448-b3f6-e063-6394a90a880d	2024-09-23	Warnings	Exact identifier application number: M016
DABUR Vitamin A and D	WHITE PETROLATUM	Dabur India Limited	22cd44ef-4b02-604d-e063-6394a90a7a0a	2024-09-23	Warnings	Exact identifier application number: M016
DABUR ZINC OXIDE 3.8%	ZINC OXIDE	Dabur India Limited	2290bbe2-8a88-b94e-e063-6294a90a7e38	2024-09-20	Warnings	Exact identifier application number: M016
Aveeno Baby Daily Moisture	DIMETHICONE	Kenvue Brands LLC	b34c8e71-7fad-484c-b387-3c424f50b743	2024-09-19	Warnings	Exact identifier application number: M016
Evereden Intensive Eczema Balm	COLLOIDAL OATMEAL	Eden Brands Inc.	2243d4ca-5ca4-54d0-e063-6394a90a3940	2024-09-16	Warnings	Exact identifier application number: M016
Whipped Gel	COLLOIDAL OATMEAL	OCEAN OLIVE LLC	222b381c-665e-177d-e063-6394a90a3306	2024-09-15	Warnings	Exact identifier application number: M016
BioBarrier Renewal Cream	ALLANTOIN	bluemercury	1ee15f84-0561-3cd2-e063-6394a90ab68e	2024-09-15	Warnings	Exact identifier application number: M016
Calamine	CALAMINE AND ZINC OXIDE	Strategic Sourcing Services, LLC	22173332-9d09-768c-e063-6394a90a94e1	2024-09-14	Warnings	Exact identifier application number: M016
Diaper Rash Cream 5.6oz	ZINC OXIDE	China Ningbo Shangge Cosmetics Technology Corp.	21a7c4ce-1360-931c-e063-6294a90aa66d	2024-09-11	Warnings	Exact identifier application number: M016
Healing Cream 3oz	PETROLATUM	China Ningbo Shangge Cosmetics Technology Corp.	21bdbb13-cc64-b5d7-e063-6294a90ae3fd	2024-09-11	Warnings	Exact identifier application number: M016
Healing Cream15oz	PETROLATUM	Rejoice International Corp.	21e4026c-d3da-e4f7-e063-6394a90aabed	2024-09-11	Warnings	Exact identifier application number: M016
Baby Balm Stick 0.65oz	PETROLATUM OINTMENT	China Ningbo Shangge Cosmetics Technology Corp.	21c0b614-ea19-e98d-e063-6294a90ac44e	2024-09-10	Warnings	Exact identifier application number: M016
Aveeno Skin Relief Moisturizing Fragrance Free	DIMETHICONE	Kenvue Brands LLC	65476a2a-8cd4-4477-ac27-9a06f41e4711	2024-09-09	Warnings	Exact identifier application number: M016
Diaper Rash Cream 15oz	ZINC OXIDE	Rejoice International Corp.	213213ab-f935-a62e-e063-6394a90af96b	2024-09-03	Warnings	Exact identifier application number: M016
Diaper Rash Cream 5.6oz	ZINC OXIDE	Rejoice International Corp.	2133876b-eaf0-f988-e063-6394a90aae4d	2024-09-03	Warnings	Exact identifier application number: M016
Baby Balm Stick 0.65oz	PETROLATUM	Rejoice International Corp.	20cf3bb8-4ab8-2980-e063-6294a90ad631	2024-08-29	Warnings	Exact identifier application number: M016
SUDOCREM SKIN PROTECTANT	ZINC OXIDE	LEDA INNOVATIONS USA, INC.	20d2cf0b-d237-fd78-e063-6394a90a8d03	2024-08-29	Warnings	Exact identifier application number: M016
Healing Cream 3oz	PETROLATUM	Rejoice International Corp.	20c9b964-c9af-d63a-e063-6294a90ab979	2024-08-28	Warnings	Exact identifier application number: M016
Babyganics Soothing Itch	OATMEAL	KAS Direct, LLC	5c2806fb-5af4-4532-b31a-be77bb23b277	2024-08-28	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