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 106 of 191 · 3,811 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BioTox Dental Foci Repair	ARNICA MONTANA, HYPERICUM PERFORATUM, PLANTAGO MAJOR, ACONITUM NAPELLUS, MERCURIUS SOLUBILIS, HEKLA LAVA, ARGENTUM NITRICUM, BELLADONNA, HEPAR SULPHURIS CALCAREUM, SILICEA	The Wellness Center For Research and Education	767f8dd2-759f-4662-9b5c-b8832309363d	2025-06-06	Warnings	Exact identifier unii: ETJ7Z6XBU4
Rodan and Fields Reverse Brightening Defense Broad Spectrum SPF 50 Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Rodan & Fields Beauty, LLC	afa2d42e-b54d-4843-b313-0c44fe5c5d52	2025-06-06	Warnings	Exact identifier unii: 15FIX9V2JP
Silicea 6X	SILICEA 6X	True Botanica, LLC	2cee8f0b-6d28-75e4-e063-6294a90a2e15	2025-06-05	Warnings	Exact identifier unii: ETJ7Z6XBU4
Body Glove Sunscreen SPF 30	ZINC OXIDE, TITANIUM DIOXIDE	SCUBASCREEN LLC	1d7a960c-4387-44dc-8d4e-881e21a8ae2e	2025-06-05	Warnings	Exact identifier unii: 15FIX9V2JP
Non Tinted Mineral Sunscreen Stick	TITANIUM DIOXIDE, ZINC OXIDE	BABYFACE LLC	36d7c8b3-554f-78d9-e063-6394a90a80f3	2025-06-05		Exact identifier unii: 15FIX9V2JP
Tinted Mineral Sunscreen Stick	TITANIUM DIOXIDE, ZINC OXIDE	BABYFACE LLC	36d80422-943f-3aba-e063-6294a90afb59	2025-06-05		Exact identifier unii: 15FIX9V2JP
Mineral Creme SPF 50 Mineral Creme SPF 50 Broad Spectrum UVA-UVB Sunscreen Water Resistant (80 min)	TITANIUM DIOXIDE AND ZINC OXIDE	MDSolarSciences	f8e178d6-058c-462a-8e59-6721f28ad040	2025-06-05	Warnings	Exact identifier unii: 15FIX9V2JP
Mineral Tinted SPF 30 Mineral Tinted SPF 30 Broad Spectrum Sunscreen Water Resistant (80 min)	TITANIUM DIOXIDE AND ZINC OXIDE	MDSolarSciences	adcd6881-fa25-4312-95e5-5b47102aa6b9	2025-06-05	Warnings	Exact identifier unii: 15FIX9V2JP
Mineral Moisture Defense SPF 50	TITANIUM DIOXIDE AND ZINC OXIDE	MDSolarSciences	05ad73f3-a4e8-4f78-8212-3e8e3bda988c	2025-06-05	Warnings	Exact identifier unii: 15FIX9V2JP
Solar SPF 40 Broad Spectrum SPF 40 Water Resistant (80 min) Mineral Suncreen	TITANIUM DIOXIDE AND ZINC OXIDE	MDSolarSciences	6ce602bb-c1f4-43c1-ae61-0f05d7952db3	2025-06-05	Warnings	Exact identifier unii: 15FIX9V2JP
Solar stick Tinted SPF 40 Tinted Broad Spectrum SPF 40 Water Resistant (80 min) Mineral Suncreen	TITANIUM DIOXIDE AND ZINC OXIDE	MDSolarSciences	b8f08778-7e5e-4341-9a24-1ce57c6525c7	2025-06-05	Warnings	Exact identifier unii: 15FIX9V2JP
Nemah SPF 30 Mineral C/S Broad Spectrum SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Nemah, Inc.	36da2d94-fa90-b145-e063-6394a90a5854	2025-06-05	Warnings	Exact identifier unii: 15FIX9V2JP
Mineral KidStick SPF 40 Mineral Broad Spectrum SPF 40 Sunscreen UVA-UVB Suncreen	TITANIUM DIOXIDE AND ZINC OXIDE	MDSolarSciences	4c7f0257-fa12-40d6-9516-824b0e3a182c	2025-06-05	Warnings	Exact identifier unii: 15FIX9V2JP
Mineral KidCreme SPF 50	TITANIUM DIOXIDE AND ZINC OXIDE	MDSolarSciences	9ec56c68-6fea-444b-aeed-0b5d60c42e75	2025-06-05	Warnings	Exact identifier unii: 15FIX9V2JP
Aveeno Calm Plus Restore Daily Moisturizer Mineral Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Kenvue Brands LLC	fbf8be03-93e2-4d7e-e053-6294a90a4fd5	2025-06-04	Warnings	Exact identifier unii: 15FIX9V2JP
Age Defense for Eyes 5 in 1	ZINC OXIDE AND TITANIUM DIOXIDE	Topiderm, Inc.	48d5343a-1068-4c64-a275-c180026d6947	2025-06-03	Warnings	Exact identifier unii: 15FIX9V2JP
Bluevado Sunfix	ZINC OXIDE, TITANIUM DIOXIDE	Magic Blue, LLC	31f1e961-3719-f70a-e063-6394a90a481e	2025-05-31	Warnings	Exact identifier unii: 15FIX9V2JP
Dr. Mercola Broad Spectrum	TITANIUM DIOXIDE, ZINC OXIDE	Natural Health Partners, LLC	47f6ab9e-fa73-496a-e054-00144ff8d46c	2025-05-28	Warnings	Exact identifier unii: 15FIX9V2JP
allergy relief d	LORATADINE, PSEUDOEPHEDRINE SULFATE	Meijer Distribution Inc	dd19215c-0da7-483a-88e3-6a32ac210c4c	2025-05-28	Warnings	Exact identifier unii: Y9DL7QPE6B unii: 7AJO3BO7QN
Allergy Relief-D	LORATADINE AND PSEUDOEPHEDRINE SULFATE	HEB	36230417-8687-d9fd-e063-6394a90ac2e5	2025-05-27	Warnings	Exact identifier rxcui: 1117562 unii: Y9DL7QPE6B unii: 7AJO3BO7QN

Reported adverse events (FAERS/openFDA)#

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