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 159 of 189 · 3,774 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Systane Lubricant	POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL	Alcon Laboratories, Inc.	15bc06ec-f3dc-3180-ca1a-106769a770ea	2023-12-15	Warnings	Exact identifier unii: 6DC9Q167V3
Systane ULTRA	POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL	Alcon Laboratories, Inc.	a5c1c194-3db5-4f18-9cd1-97f7f84c3cff	2023-12-15	Warnings	Exact identifier unii: 6DC9Q167V3
La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum SPF 40 Medium	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc	1f3b56d5-c33a-401f-8c8a-924345a4846e	2023-12-15	Warnings	Exact identifier unii: 15FIX9V2JP
Rejuvity moisturizing day cream BROAD SPECTRUM SPF 15 SUNSCREEN	TITANIUM DIOXIDE, ZINC OXIDE	Isagenix International, LLC	6d2d5590-5f53-48d9-94c5-fe9f6a5cf3ce	2023-12-14	Warnings	Exact identifier unii: 15FIX9V2JP
Systane COMPLETE PF	PROPYLENE GLYCOL	Alcon Laboratories, Inc.	7eaa93ca-c843-4c89-921b-c76659410dce	2023-12-14	Warnings	Exact identifier unii: 6DC9Q167V3
GenTeal Tears Gel Drops	POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL	Alcon Laboratories, Inc.	84388a75-9d11-48ce-bf5a-88f0580d2d03	2023-12-14	Warnings	Exact identifier unii: 6DC9Q167V3
BSS	BALANCED SALT SOLUTION	Alcon Laboratories, Inc.	28488c7b-cf6a-4a03-916f-cc66b3afdc57	2023-12-14	Warnings, Adverse reactions	Exact identifier unii: 1Q73Q2JULR
bareMinerals BAREPRO Performance Wear Liquid Foundation Broad Spectrum SPF 20 Fair 01	TITANIUM DIOXIDE	Orveon Global US LLC	29738578-6681-476e-8660-7219f58e8fa0	2023-12-13	Warnings	Exact identifier unii: 15FIX9V2JP
La Roche Posay Laboratoire Dermatologique Anthelios 50 Mineral Ultra Light Broad Spectrum SPF 50 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Cosmetique Active Production	4e56f3f2-b856-4bbc-ab39-6fb5887a4846	2023-12-13	Warnings	Exact identifier unii: 15FIX9V2JP
La Roche Posay Laboratoire Dermatologique Anthelios 50 Mineral Ultra Light Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc	2ce83dc2-84b6-43fd-8b11-495d41cebc22	2023-12-13	Warnings	Exact identifier unii: 15FIX9V2JP
La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Face Broad Spectrum SPF 50 Sunscreen	TITANIUM DIOXIDE	Cosmetique Active Production	4d5d1e79-7b3e-41b5-ae6b-a3b0265702ca	2023-12-13	Warnings	Exact identifier unii: 15FIX9V2JP
RODAN FIELDS SOOTHE 4 Mineral Sunscreen BROAD SPECTRUM SPF 30	TITANIUM DIOXIDE	Rodan & Fields	1a936053-2be0-4c52-a073-ba846b87f811	2023-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
Broad Spectrum SPF 30 Up The Anti	TITANIUM DIOXIDE, ZINC OXIDE	Biopelle, Inc.	37506766-370e-4ae4-8dbe-915a763e7c55	2023-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
Youth Activating BB SPF30 Shade 3	ZINC OXIDE, TITANIUM DIOXIDE	Englewood Lab, Inc.	c84207c4-a779-4c00-a486-86eaf8ece169	2023-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
MD Mineral BB Creme Broad Spectrum SPF 50 Water Resistant 80 Min	TITANIUM DIOXIDE, ZINC OXIDE	ENGLEWOOD LAB, INC.	5742da4b-6713-4de9-8ab8-b2bf2983371a	2023-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
Laura Mercier Flawless Skin Daily Face Shield SPF 40	OCTINOXATE, TITANIUM DIOXIDE	Gurwitch Products, LLC	f86729cd-682f-47b2-9bfa-1113721bfec0	2023-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
Boscia BB SPF 27 PA	TITANIUM DIOXIDE	Boscia LLC	5dc86c0b-c340-4643-a174-a6b4c0826ca9	2023-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
Boscia BB Broad Spectrum SPF 27 PA Self Adjusting Shade	TITANIUM DIOXIDE, ZINC OXIDE	Boscia LLC	82a23aab-404f-46bb-afaa-8ba9b9bdbefd	2023-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
Boscia BB BRONZE Broad Spectrum SPF 27 PA Self-Adjusting Shade	TITANIUM DIOXIDE, ZINC OXIDE	Boscia LLC	5f5fb9f5-00be-420a-b19a-b753c45f9a88	2023-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
3LAB Aqua BB SPF 40 BROAD SPECTRUM 03	TITANIUM DIOXIDE	3LAB, Inc.	8a42a9d8-b9c6-45fb-8264-15f36e2765f0	2023-12-12	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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