NDC 62011-0071-01 - Loratadine and Pseudoephedrine Sulfate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 62011-0071
Requested NDC: 62011-0071-01
Package NDCs from labels: 62011-0071-2, 62011-0071-1, 62011-0071-01
Manufacturer: Strategic Sourcing Services LLC | Sun Pharmaceutical Industries Inc. | Ohm Laboratories Inc.
Effective date: 2024-11-22
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Drug Facts	Strategic Sourcing Services LLC \| Sun Pharmaceutical Industries Inc. \| Ohm Laboratories Inc.	2024-11-22	HUMAN OTC DRUG LABEL
Drug Facts	Strategic Sourcing Services LLC \| Sun Pharmaceutical Industries Inc. \| Ohm Laboratories Inc.	2024-11-21	HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62011-0071-1	Loratadine and Pseudoephedrine Sulfate	10 in 1 BLISTER PACK	TABLET, FILM COATED, EXTENDED RE	10		5
62011-0071-2	Loratadine and Pseudoephedrine Sulfate	15 in 1 BLISTER PACK	TABLET, FILM COATED, EXTENDED RE	15		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62011-0071	LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [STRATEGIC SOURCING SERVICES LLC]	5	Current NDC, Legacy NDC, 1 package rows	20241123_48bfc938-d97d-4b49-8637-3b00ac870902.zip
62011-0071	LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [STRATEGIC SOURCING SERVICES LLC]	5	Current NDC, Legacy NDC, 1 package rows	20241123_cdecad62-bf1e-43fb-b4be-8fc54b63e4ae.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62011-0071-1	EA - Each	62011-0071	cf52c418-ca82-42f1-b496-6f064a51b458	1	2013-02-13
62011-0071-2	EA - Each	62011-0071	1e1c366c-ae3e-4271-a99e-69ba07bbf210	1	2018-03-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LORATADINE	ACTIVE INGREDIENT	7AJO3BO7QN	LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEALTH MART]	1
PSEUDOEPHEDRINE SULFATE	ACTIVE INGREDIENT	Y9DL7QPE6B	LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEALTH MART]	1
LORATADINE	ACTIVE MOIETY	7AJO3BO7QN	LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEALTH MART]	1
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEALTH MART]	1
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEALTH MART]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEALTH MART]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEALTH MART]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEALTH MART]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEALTH MART]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEALTH MART]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEALTH MART]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEALTH MART]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEALTH MART]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEALTH MART]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEALTH MART]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEALTH MART]	1
SODIUM ALGINATE	INACTIVE INGREDIENT	C269C4G2ZQ	LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEALTH MART]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEALTH MART]	1
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEALTH MART]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEALTH MART]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [HEALTH MART]	1

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 59 of 194 · 3,866 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tinted Mineral Sunscreen Broad Spectrum SPF 40	TITANIUM DIOXIDE, ZINC OXIDE	WECARE FRISCO PLLC	374f866d-eb52-61e3-e063-6394a90a77c7	2025-12-16		Exact identifier unii: 15FIX9V2JP
Tinted Lip Protection	TITANIUM DIOXIDE, ZINC OXIDE	WECARE FRISCO PLLC	3750c23d-c3f8-fac3-e063-6394a90a135e	2025-12-16		Exact identifier unii: 15FIX9V2JP
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	KATHY JONES AESTHETHICS LLC	37dab729-5988-5eba-e063-6294a90ac6b7	2025-12-16		Exact identifier unii: 15FIX9V2JP
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Tory Sullivan, M.D., P.A.	36241e60-f02a-50a7-e063-6394a90a6390	2025-12-16		Exact identifier unii: 15FIX9V2JP
UV Defense Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	CCLEAR SOLUTIONS ACNE & SKIN CARE CLINIC	365e09a8-308b-b753-e063-6394a90ae9e5	2025-12-16		Exact identifier unii: 15FIX9V2JP
UV Defense Mineral Sunscreen Tinted	TITANIUM DIOXIDE, ZINC OXIDE	CCLEAR SOLUTIONS ACNE & SKIN CARE CLINIC	365e2498-7df2-f22c-e063-6294a90ac6ab	2025-12-16		Exact identifier unii: 15FIX9V2JP
UV Protection Veil Mineral Sunscreen non tinted	TITANIUM DIOXIDE, ZINC OXIDE	ATHENA PLASTIC SURGERY	3b3bf5a6-33ec-0255-e063-6294a90ac96a	2025-12-16	Warnings	Exact identifier unii: 15FIX9V2JP
UV Protection Veil Mineral Sunscreen, tinted	TITANIUM DIOXIDE, ZINC OXIDE	ATHENA PLASTIC SURGERY	3b3cba2e-acc6-a2df-e063-6294a90abf71	2025-12-16	Warnings	Exact identifier unii: 15FIX9V2JP
UV Protection Veil Mineral Sunscreen, tinted	TITANIUM DIOXIDE, ZINC OXIDE	ATHENA PLASTIC SURGERY	3b3c757f-6581-4978-e063-6294a90a6173	2025-12-16	Warnings	Exact identifier unii: 15FIX9V2JP
Virgo SOL Primer Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	ULTRAVIOLET SKINCARE LLC	369d4f43-8c57-9fcf-e063-6294a90aa916	2025-12-16		Exact identifier unii: 15FIX9V2JP
Virgo SOL Non Tinted Mousse	TITANIUM DIOXIDE, ZINC OXIDE	ULTRAVIOLET SKINCARE LLC	369d63a9-b9ab-9530-e063-6394a90ac8ef	2025-12-16		Exact identifier unii: 15FIX9V2JP
Kind Restore Moisturizing Lip Balm	TITANIUM DIOXIDE, ZINC OXIDE	POLISH BEAUTY	39814e27-4f3f-5ee6-e063-6394a90a941b	2025-12-16		Exact identifier unii: 15FIX9V2JP
Dr B Clinical Skin Care Tinted Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	NAIRA BABAIAN, M.D., P.A.	365da1f8-5250-7589-e063-6294a90a3e68	2025-12-16		Exact identifier unii: 15FIX9V2JP
Dr B Clinical Skin Care Non Tinted Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	NAIRA BABAIAN, M.D., P.A.	365d7564-3025-257b-e063-6294a90ad170	2025-12-16		Exact identifier unii: 15FIX9V2JP
Matte Defense Mineral Sunscreen non tinted	TITANIUM DIOXIDE, ZINC OXIDE	PURE VITALITY SKIN AND BODY, INC	3698090a-1639-00f9-e063-6394a90a7dd1	2025-12-16		Exact identifier unii: 15FIX9V2JP
Tinted Mineral Primer SPF 40	TITANIUM DIOXIDE, ZINC OXIDE	JOSEPHINA RAMIREZ	365cf2be-8862-3622-e063-6394a90ac4e3	2025-12-16		Exact identifier unii: 15FIX9V2JP
SANCTUARY Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	CHAMPAGNE APOTHECARY LLC	365ca99c-c878-1f4b-e063-6394a90a1f53	2025-12-16		Exact identifier unii: 15FIX9V2JP
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	MILL VALLEY DERMATOLOGY, INC.	3b171a89-c757-47a1-e063-6294a90a7a64	2025-12-16	Warnings	Exact identifier unii: 15FIX9V2JP
Silk Screen Tinted	TITANIUM DIOXIDE, ZINC OXIDE	Skin Science Institute Inc	36c3793a-ccb5-1e5f-e063-6294a90ad44f	2025-12-16		Exact identifier unii: 15FIX9V2JP
Silk Screen Tinted	TITANIUM DIOXIDE, ZINC OXIDE	Skin Science Institute Inc	36c3a721-6be1-3f7f-e063-6394a90a522f	2025-12-16		Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.