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 125 of 190 · 3,788 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NORWEX Protect Prevent Mineral Facial Sunscreen Broad Spectrum SPF30	TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, CORPORATION	0d489154-6168-977e-e063-6394a90aa609	2024-12-26	Warnings	Exact identifier unii: 15FIX9V2JP
ANTACID	CALCIUM CARBONATE	Advance Pharmaceutical Inc.	face4e8c-3d0f-4c2e-83c1-44397b225ae7	2024-12-26	Warnings	Exact identifier unii: H0G9379FGK
ANTACID	CALCIUM CARBONATE	Advance Pharmaceutical Inc.	3203dfc5-2cb1-4703-8d81-63fba07ddd98	2024-12-26	Warnings	Exact identifier unii: H0G9379FGK
HEB Extra Strength Smooth Antacid Assorted Fruits	CALCIUM CARBONATE	H E B	2faac316-7b59-4df8-b751-37069e865263	2024-12-26	Warnings	Exact identifier unii: H0G9379FGK
Good Neighbor Pharmacy Antacid Extra Strength	CALCIUM CARBONATE	AmerisourceBergen Drug Corporation	5e3a3c20-dabe-4427-9e75-99759905caa0	2024-12-26	Warnings	Exact identifier unii: H0G9379FGK
HEB Extra Strength Smooth Antacid Peppermint	CALCIUM CARBONATE	H E B	d04e691e-6d1c-4c39-9504-7ac0f1bd197d	2024-12-26	Warnings	Exact identifier unii: H0G9379FGK
CITY BLOCK SHEER Oil FREE DAILY FACE PROTECTOR BROAD SPECTRUM SPF 25	TITANIUM DIOXIDE AND ZINC OXIDE	CLINIQUE LABORATORIES LLC	ee7e2ded-b850-4e15-96a6-556111e52187	2024-12-25	Warnings	Exact identifier unii: 15FIX9V2JP
CLINIQUE SUPER DEFENSE CITY BLOCK DAILY ENERGY PLUS FACE PROTECTOR BROAD SPECTRUM SPF 50	OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE	CLINIQUE LABORATORIES LLC	d1a3d76f-16dd-4533-8144-9a3175f6e15f	2024-12-25	Warnings	Exact identifier unii: 15FIX9V2JP
DOUBLE WEAR MAXIMUM COVER CAMOUFLAGE MAKEUP FOR FACE AND BODY BROAD SPECTRUM SPF 15	TITANIUM DIOXIDE	ESTEE LAUDER INC	a04a9aaa-fa0f-4dde-a7a5-c4c561cc51b1	2024-12-25	Warnings	Exact identifier unii: 15FIX9V2JP
STUDIO FIX FLUID SPF 15 BROAD SPECTRUM	OCTINOXATE AND TITANIUM DIOXIDE	MAKEUP ART COSMETICS	ff48435d-245a-4037-9afb-caee83c4c415	2024-12-25	Warnings	Exact identifier unii: 15FIX9V2JP
ORIGINS GINZING ENERGY-BOOSTING TINTED MOISTURIZER BROAD SPECTRUM SPF 40	OCTINOXATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE	ORIGINS NATURAL RESOURCES INC.	0fe63edf-7a49-4b33-88f1-f480f889d194	2024-12-25	Warnings	Exact identifier unii: 15FIX9V2JP
LA MER THE LUMINOUS LIFTING CUSHION FOUNDATION BROAD SPECTRUM SPF 20	TITANIUM DIOXIDE	MAX HUBER RESEARCH LAB INC	66e48ce0-9a5b-4250-b07b-1622b3814c3e	2024-12-25	Warnings	Exact identifier unii: 15FIX9V2JP
ESTEE LAUDER DOUBLE WEAR SHEER LONG-WEAR MAKEUP BROAD SPECTRUM SPF 19	OCTINOXATE AND TITANIUM DIOXIDE	ESTEE LAUDER INC	2f93580c-c8e9-4822-91bf-a749cf4deb4e	2024-12-25	Warnings	Exact identifier unii: 15FIX9V2JP
Almay Age Smart Shade CC Luminous Primer SPF 15	ZINC OXIDE, TITANIUM DIOXIDE MAKE-UP	Almay, Inc.	281557c0-e668-4436-86a7-3f583091e4e4	2024-12-24	Warnings	Exact identifier unii: 15FIX9V2JP
RV Illuminance Serum Tint Broad Spectrum 15 Amber	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	2a0b311f-9dcc-9b26-e063-6394a90a29a8	2024-12-24	Warnings	Exact identifier unii: 15FIX9V2JP
RV Illuminance Serum Tint Broad Spectrum 15 Buff Beige	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	2a0b3b8b-d38b-cd4d-e063-6294a90a919a	2024-12-24	Warnings	Exact identifier unii: 15FIX9V2JP
RV Illuminance Serum Tint Broad Spectrum 15 Hazel	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	2a0b3b8b-d38c-cd4d-e063-6294a90a919a	2024-12-24	Warnings	Exact identifier unii: 15FIX9V2JP
RV Illuminance Serum Tint Broad Spectrum 15 Cool Beige	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	2a0b48b8-5953-9ab7-e063-6394a90a6b24	2024-12-24	Warnings	Exact identifier unii: 15FIX9V2JP
RV Illuminance Serum Tint Broad Spectrum 15 Creamy Natural	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	2a0b311f-9dcd-9b26-e063-6394a90a29a8	2024-12-24	Warnings	Exact identifier unii: 15FIX9V2JP
RV Illuminance Serum Tint Broad Spectrum 15 Rich Mahogany	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	2a0b6b99-883b-ffd4-e063-6294a90a7f4b	2024-12-24	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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