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 92 of 191 · 3,811 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Perricone MD HIGH POTENCY CLASSICS Face Finishing and Firming Tinted Moisturizer Broad Spectrum SPF 30	TITANIUM DIOXIDE	THG Beauty USA LLC	38c80373-1d5a-c7f4-e063-6294a90aa9c2	2025-10-23	Warnings	Exact identifier unii: 15FIX9V2JP
Perricone MD Cold Plasma Plus Daily Defense Moisturizer Broad Spectrum SPF 35	ZINC OXIDE, TITANIUM DIOXIDE	THG Beauty USA LLC	254b4692-a459-6119-e063-6394a90a0a60	2025-10-23	Warnings	Exact identifier unii: 15FIX9V2JP
Miranda Castros Healing Cell Salts For Bones, Hair, Nails, and Teeth	CALCAREA FLUORICA, CALCAREA PHOSPHORICA, SILICEA	MIRANDA CASTRO'S SHOP, LLC	267fb775-a03c-f100-e063-6394a90aa826	2025-10-23	Warnings	Exact identifier unii: ETJ7Z6XBU4
Miranda Castros healing cell salts for bones, hair, nails and teeth Homeopathic Combination	CALCAREA FLUORICA, CALCAREA PHOSPHORICA, SILICEA	MIRANDA CASTRO'S SHOP, LLC	266e907b-4cdb-fb4f-e063-6394a90aa434	2025-10-23	Warnings	Exact identifier unii: ETJ7Z6XBU4
Advanced Eye Relief Dry Eye Rejuvenation	GLYCERIN PROPYLENE GLYCOL	Bausch & Lomb Incorporated	027969ee-64e4-4b08-bab7-c4cc8ed22f5f	2025-10-23	Warnings	Exact identifier unii: 6DC9Q167V3
McKesson Loradatine	LORATAINDE	McKesson Medical Surgical	c6a3056e-792e-52a4-e053-2a95a90a8361	2025-10-23	Warnings	Exact identifier unii: 7AJO3BO7QN
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Latte	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	c34c1486-fa6c-485f-80b3-98e397b3dddb	2025-10-22	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Cool Vanilla	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	74c078ec-a371-4406-8d5e-a0baada3a1a6	2025-10-22	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Sandalwood	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	2765f345-eab2-4878-b1f1-f8e243083476	2025-10-22	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Toffee	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	d1181543-07ab-4a51-8b55-afc1a98293f6	2025-10-22	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Warm Beige	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	c7be3a7e-f031-4ec0-b9dc-41c025cd0066	2025-10-22	Warnings	Exact identifier unii: 15FIX9V2JP
Powder	TITANIUM DIOXIDE	Oxygen Development LLC	41c0c262-21c3-b8e6-e063-6394a90a7c9c	2025-10-22	Warnings	Exact identifier unii: 15FIX9V2JP
CVS Loratadine	LORATADINE	CVS Pharmacy	3d716988-da63-59e6-e063-6394a90a5b4b	2025-10-22	Warnings	Exact identifier unii: 7AJO3BO7QN
Exchange Select Antacid Soft Chews Cherry Flavor	CALCIUM CARBONATE	Army & Air Force Exchange Service	41ad5581-5b8a-1c8b-e063-6294a90a2ba6	2025-10-21	Warnings	Exact identifier unii: H0G9379FGK
Sonni SunDay Invisible Defense	TITANIUM DIOXIDE, ZINC OXIDE	Sonni	41ad9658-7906-d04c-e063-6394a90a4723	2025-10-21	Warnings	Exact identifier unii: 15FIX9V2JP
Sonni SunDay Body Balm	TITANIUM DIOXIDE, ZINC OXIDE	Sonni	41adca2e-cf69-ccd9-e063-6294a90a0dc0	2025-10-21	Warnings	Exact identifier unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Deep 530 W	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	940e0b2d-0b10-4534-ba36-e9980cead492	2025-10-21	Warnings	Exact identifier unii: 15FIX9V2JP
iVIZIA Dry Eye	POVIDONE	Thea Pharma Inc.	1ef73cb1-da48-a713-e063-6294a90afa9d	2025-10-20	Warnings	Exact identifier unii: FZ989GH94E
Clinical Skin Filter Tinted Sunscreen	CLINICAL SKIN FILTER TINTED SUNSCREEN	KRX RESOURCES SDN. BHD.	22b8856b-671f-def3-e063-6394a90a4ea0	2025-10-18	Warnings	Exact identifier unii: 15FIX9V2JP
Clinical Skin Filter Tinted Sunscreen Medium Dark	CLINICAL SKIN FILTER TINTED SUNSCREEN MEDIUM DARK	KRX RESOURCES SDN. BHD.	22cead37-f862-e859-e063-6394a90a86ce	2025-10-18	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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