Sunmark Caldiphen

Product NDC: 49348-337
Requested package NDC: 49348-337-36
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: PRAMOXINE HYDROCHLORIDE; ZINC OXIDE
Active strength: 10; 80 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

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	10 mg/mL
PRAMOXINE HYDROCHLORIDE	80 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 1 of 69 · 1,363 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nail Fungus Repairing Liquid	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	57b8b3e5-88be-3a91-e063-6294a90a05be	2026-07-28	Warnings	Exact identifier application number: M016
DERMFREE INSECT BITE RELIEF	SODIUM BICARBONATE 5% INSECT BITE RELIEF	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	5794886c-0d74-9f35-e063-6394a90a27d8	2026-07-27	Warnings	Exact identifier application number: M016
OKeeffes Lip Repair SEAL and HEAL	PETROLATUM	The Gorilla Glue Company/O'Keeffe's Company	55f66f54-da39-76c7-e063-6394a90aeda9	2026-07-27	Warnings	Exact identifier application number: M016
Boo Boo Magic Diaper Rash Creamy	ZINC OXIDE	Alboo Brands LLC	5114aff8-adde-e610-e063-6294a90a77ea	2026-07-27	Warnings	Exact identifier application number: M016
PrevaDRM Vitamin Repair	SKIN PROTECTANT	Sion Brands LLC	579e4639-a742-1901-e063-6294a90a2d45	2026-07-27	Warnings	Exact identifier application number: M016
Hello Bello Diaper Rash Cream	ZINC OXIDE	Topiderm, Inc.	e158ba31-e159-4624-a490-fe70baaf4a39	2026-07-24	Warnings	Exact identifier application number: M016
Gethorey Vein Target Microneedle Patch	ALLANTOIN 2% VEIN TARGET MICRONEEDLE PATCH	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	57593145-a874-15d9-e063-6294a90a77d9	2026-07-24	Warnings	Exact identifier application number: M016
Fresh Scent PROTECTIVE BABY	ZINC OXIDE	CVS Pharmacy, Inc.	3f33c62c-43ec-4576-a24d-bd5de07e74d2	2026-07-23	Warnings	Exact identifier application number: M016
Estriol Cream	ESTRIOL	Guangxi Keyun E-commerce Co., Ltd.	4deadcb6-0d46-bdd7-e063-6294a90a26d7	2026-07-23	Warnings	Exact identifier application number: M016
DERMFREE Vein Target Microneedle Patch	ALLANTOIN 1% VEIN TARGET MICRONEEDLE PATCH	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	57449e29-ec46-9c30-e063-6394a90a7b4a	2026-07-23	Warnings	Exact identifier application number: M016
Baby Vitamin A and D	LANOLIN 15.5%, PETROLATUM 53.4%	Walgreen Company	25a125ea-6f9f-310c-e063-6394a90acef2	2026-07-22	Warnings	Exact identifier application number: M016
First Aid A and D	LANOLIN 15.5%, PETROLATUM 53.4%	Walgreen Company	25a319d0-d39a-5ff0-e063-6394a90a671d	2026-07-22	Warnings	Exact identifier application number: M016
Calamine	CALAMINE AND ZINC OXIDE	Marie's Original Formulas LLC	57110309-9a3d-025f-e063-6394a90a015a	2026-07-22	Warnings	Exact identifier application number: M016
Dermasporin	LANOLIN	Marie's Original Formulas LLC	562f40aa-eeec-2b7c-e063-6294a90ad68d	2026-07-22	Warnings	Exact identifier application number: M016
CAREALL Vitamin A and D	PETROLATUM	New World Imports, Inc	ef89a68a-74c1-4c42-8078-b7a208ace0de	2026-07-22	Warnings	Exact identifier application number: M016
Dermact	LANOLIN	Marie's Original Formulas LLC	57121dbe-e886-a562-e063-6294a90a367f	2026-07-22	Warnings	Exact identifier application number: M016
Universal WITCH HAZEL	WITCH HAZEL	Universal Distribution Center LLC	7e0b56ef-fa41-4862-b387-5b58d81d67d4	2026-07-22	Warnings	Exact identifier application number: M016
Aveeno Soothing Bath Treatment	OATMEAL	Kenvue Brands LLC	0c410b8e-025f-477c-afac-6e2e9ac88f7d	2026-07-21	Warnings	Exact identifier application number: M016
DERMFREE SCAR SHEETS	SILICONE GEL 1% SCAR SHEETS	Jiangxi Yudexi Pharmaceutical Co., LTD	4a4ce316-4b92-7e81-e063-6294a90af6db	2026-07-21	Warnings	Exact identifier application number: M016
DERMFREE VARICOSE VEINS	DIMETHICONE 3% VARICOSE VEINS	Jiangxi Yudexi Pharmaceutical Co., LTD	4a5a2d1d-9e84-18eb-e063-6394a90a97ee	2026-07-21	Warnings	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
88AYB867L5	PRAMOXINE HYDROCHLORIDE	637-58-1	PRAMOXINE HYDROCHLORIDE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

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