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 167 of 186 · 3,715 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BAREMINERALS SPF 20 CORRECTING CONCEALER Dark 2	TITANIUM DIOXIDE	Orveon Global US LLC	6845acee-5a3f-4c8d-9386-8823b30373f3	2023-10-04	Warnings	Exact identifier unii: 15FIX9V2JP
bareMinerals Complexion Rescue Broad Spectrum SPF 30 Opal 01	TITANIUM DIOXIDE	Orveon Global US, LLC	798934af-f011-4a95-bdb6-b577154713c4	2023-10-04	Warnings	Exact identifier unii: 15FIX9V2JP
bareMinerals Complexion Rescue Brightening Concealer SPF 25 Deep Mahogany	TITANIUM DIOXIDE	Orveon Global US LLC	f03b4fa3-4da9-5e44-e053-2a95a90af344	2023-10-04	Warnings	Exact identifier unii: 15FIX9V2JP
bareMinerals Complexion Rescue Tinted Hydrating Broad Spectrum SPF 30 Cashew 3.5	TITANIUM DIOXIDE	Orveon Global US LLC	2de76f3c-b438-47ca-84e5-e871e9d995a4	2023-10-04	Warnings	Exact identifier unii: 15FIX9V2JP
bareMinerals Original Foundation Broad Spectrum SPF 15 Fair Ivory	TITANIUM DIOXIDE	Orveon Global US LLC	15c92bce-75f4-40e3-ae28-9bcbc241c8e9	2023-10-04	Warnings	Exact identifier unii: 15FIX9V2JP
bareMinerals Complexion Rescue Defense Radiant Protective Veil Broad Spectrum SPF 30 Soft Radiance	TITANIUM DIOXIDE AND ZINC OXIDE	Orveon Global US LLC	0c2db44d-8604-4883-ab01-f14bc441e4e4	2023-10-04	Warnings	Exact identifier unii: 15FIX9V2JP
bareMinerals Original Foundation Broad Spectrum SPF 15 Medium Beige 12	TITANIUM DIOXIDE AND ZINC OXIDE	Orveon Global US LLC	3c35fd13-1a4b-4acf-ada4-16ee2e52dd94	2023-10-04	Warnings	Exact identifier unii: 15FIX9V2JP
bareMinerals Prime Time BB Primer-Cream Broad Spectrum SPF 30 Medium	TITANIUM DIOXIDE AND ZINC OXIDE	Orveon Global US LLC	3cc5b952-4619-4395-97c0-5b68efa9af6d	2023-10-04	Warnings	Exact identifier unii: 15FIX9V2JP
bareMinerals Skinlongevity Vital Power Moisturizer Broad Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	Orveon Global US LLC	29c25bc3-902a-41af-996a-8c7e8a4bf574	2023-10-04	Warnings	Exact identifier unii: 15FIX9V2JP
bareMinerals Original Foundation Broad Spectrum SPF 15 Fairly Light 03	TITANIUM DIOXIDE	Orveon Global US LLC	b2909888-5a98-4894-a895-230aa53f64d9	2023-10-04	Warnings	Exact identifier unii: 15FIX9V2JP
bareMinerals Original Foundation Broad Spectrum SPF 15 Tan 19	TITANIUM DIOXIDE AND ZINC OXIDE	Orveon Global US LLC	a5888955-f381-4209-9589-bd2e79a84f59	2023-10-04	Warnings	Exact identifier unii: 15FIX9V2JP
bareMinerals Original Foundation Broad Spectrum SPF 15 Light 08	TITANIUM DIOXIDE AND ZINC OXIDE	Orveon Global US LLC	ad15bdee-67e6-4281-8144-e84b7c478a34	2023-10-04	Warnings	Exact identifier unii: 15FIX9V2JP
bareMinerals Original Foundation Broad Spectrum SPF 15 Medium Tan 18	TITANIUM DIOXIDE AND ZINC OXIDE	Orveon Global US LLC	aa4d7945-6cc9-4f20-b588-a5588e57d30a	2023-10-04	Warnings	Exact identifier unii: 15FIX9V2JP
bareMinerals Original Foundation Broad Spectrum SPF 15 Golden Tan 20	TITANIUM DIOXIDE AND ZINC OXIDE	Orveon Global US LLC	2f8b6c57-dcae-408e-898d-d5630deeb090	2023-10-04	Warnings	Exact identifier unii: 15FIX9V2JP
bareMinerals Original Foundation Broad Spectrum SPF 15 Golden Fair 04	TITANIUM DIOXIDE AND ZINC OXIDE	Orveon Global US LLC	e486915b-8097-451a-a018-3279213239b3	2023-10-04	Warnings	Exact identifier unii: 15FIX9V2JP
bareMinerals Original Foundation Broad Spectrum SPF 15 Golden Deep 28	TITANIUM DIOXIDE AND ZINC OXIDE	Orveon Global US LLC	5b51df09-40c3-4064-96d3-b7366fc83826	2023-10-04	Warnings	Exact identifier unii: 15FIX9V2JP
bareMinerals Original Foundation Broad Spectrum SPF 15 Fairly Medium 05	TITANIUM DIOXIDE AND ZINC OXIDE	Orveon Global US LLC	f1714e23-030c-4bd9-b9e7-111c3813ed34	2023-10-04	Warnings	Exact identifier unii: 15FIX9V2JP
bareMinerals Original Foundation Broad Spectrum SPF 15 Medium Dark 23	TITANIUM DIOXIDE AND ZINC OXIDE	Orveon Global US LLC	828fe263-f223-45c3-9710-fd8d59ad56b1	2023-10-04	Warnings	Exact identifier unii: 15FIX9V2JP
bareMinerals Multi-Tasking SPF 20 Concealer Bisque	TITANIUM DIOXIDE	Orveon Global US LLC	d4c30bea-8c56-4ed8-8ec4-f1b1e0e456dd	2023-10-04	Warnings	Exact identifier unii: 15FIX9V2JP
BareMinerals Mineral Veil	TITANIUM DIOXIDE AND ZINC OXIDE	Orveon Global US LLC	64b163dd-8a86-483f-8dab-80fa8740b12f	2023-10-04	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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