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 63 of 194 · 3,866 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
REJUVN8	TITANIUM DIOXIDE, ZINC OXIDE	FLEUR DE VIE LLC	37ede476-43b6-a7c8-e063-6294a90a3e8f	2025-12-15		Exact identifier unii: 15FIX9V2JP
REJUVN8	TITANIUM DIOXIDE, ZINC OXIDE	FLEUR DE VIE LLC	37efa5e1-e88e-d251-e063-6394a90a9371	2025-12-15		Exact identifier unii: 15FIX9V2JP
Non-Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	THE BEAUTY ROOM OC INC	3dd330bf-92e4-3664-e063-6294a90a0475	2025-12-15	Warnings	Exact identifier unii: 15FIX9V2JP
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	THE BEAUTY ROOM OC INC	3dd37dd1-fd43-7af4-e063-6394a90ae3a0	2025-12-15	Warnings	Exact identifier unii: 15FIX9V2JP
Non-Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	THE BEAUTY ROOM OC INC	3dd3dcab-e9fb-0ef5-e063-6394a90acef1	2025-12-15	Warnings	Exact identifier unii: 15FIX9V2JP
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	THE BEAUTY ROOM OC INC	3dd40a6a-d52e-ab87-e063-6294a90a966e	2025-12-15	Warnings	Exact identifier unii: 15FIX9V2JP
Mattifying Skin Primer	TITANIUM DIOXIDE, ZINC OXIDE	SKIN MAVEN	37662032-2842-1982-e063-6294a90a49a0	2025-12-15		Exact identifier unii: 15FIX9V2JP
Deluxe Lip Protection	TITANIUM DIOXIDE, ZINC OXIDE	BIOHEALTH PLUS LLC	37657895-5fec-82d0-e063-6294a90acf67	2025-12-15		Exact identifier unii: 15FIX9V2JP
Facial Mineral Fusion	TITANIUM DIOXIDE, ZINC OXIDE	IT INTELLIGENT TREATMENT LLC	35944621-e6fb-cd98-e063-6294a90aa641	2025-12-15		Exact identifier unii: 15FIX9V2JP
Mineral Mousse	TITANIUM DIOXIDE, ZINC OXIDE	CLARITY SKIN CARE STUDIO, INC.	35d00778-3857-ce8f-e063-6394a90ab375	2025-12-15		Exact identifier unii: 15FIX9V2JP
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	R. Sonia Batra, MD, Inc.	35933039-8beb-9f98-e063-6394a90a60bb	2025-12-15		Exact identifier unii: 15FIX9V2JP
Non-Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	R. Sonia Batra, MD, Inc.	3592edca-cab0-6c44-e063-6294a90a1727	2025-12-15		Exact identifier unii: 15FIX9V2JP
Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Healthy Skin & Body LLC	38046e71-f171-7e96-e063-6294a90a1f0b	2025-12-15		Exact identifier unii: 15FIX9V2JP
Barrier Plus Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Healthy Skin & Body LLC	38038beb-d0f0-ced2-e063-6294a90ac423	2025-12-15		Exact identifier unii: 15FIX9V2JP
Happy Mineral Sunscreen Primer SPF	TITANIUM DIOXIDE, ZINC OXIDE	ACNE CLINIC LAS VEGAS BY JUSTINA	37d9c5f2-f414-6efa-e063-6294a90a927f	2025-12-15		Exact identifier unii: 15FIX9V2JP
Comfort Mineral Mousse Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	BIOHEALTH PLUS LLC	3765dd17-ffbd-bcf4-e063-6394a90a2c2b	2025-12-15		Exact identifier unii: 15FIX9V2JP
Prime And Protect Matte	TITANIUM DIOXIDE, ZINC OXIDE	Kalon Skin Studio, LLC	35939630-1166-1c70-e063-6294a90aac6b	2025-12-15		Exact identifier unii: 15FIX9V2JP
Tinted Lip Balm	TITANIUM DIOXIDE, ZINC OXIDE	Goldberg, Howard S MD Inc	3598205d-2e87-9292-e063-6294a90a1f2a	2025-12-15		Exact identifier unii: 15FIX9V2JP
Advanced Formula Non-Tinted	TITANIUM DIOXIDE, ZINC OXIDE	CR KEEFE ENTERPRISES, INC.	3981c878-826d-f685-e063-6294a90acb24	2025-12-15		Exact identifier unii: 15FIX9V2JP
Advanced Formula Tinted	TITANIUM DIOXIDE, ZINC OXIDE	CR KEEFE ENTERPRISES, INC.	3984c4b7-94ee-2a8e-e063-6294a90ac24f	2025-12-15		Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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