NDC 62011-0475-01 - Guaifenesin and Pseudoephedrine Hydrochloride

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: 62011-0475
Requested NDC: 62011-0475-01
Package NDCs from labels: 62011-0475-1, 62011-0475-01
Manufacturer: STRATEGIC SOURCING SERVICES LLC | Ohm Laboratories Inc.
Effective date: 2022-02-08
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Guaifenesin and Pseudoephedrine Hydrochloride	STRATEGIC SOURCING SERVICES LLC \| Ohm Laboratories Inc.	2022-02-08	HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62011-0475-1	Guaifenesin and Pseudoephedrine Hydrochloride	18 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	18		2
62011-0475-1	Guaifenesin and Pseudoephedrine Hydrochloride	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62011-0475	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [STRATEGIC SOURCING SERVICES LLC]	2	Current NDC, Legacy NDC, 2 package rows	20220210_d139fd8d-66fd-4484-8e78-ed90c505d999.zip

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 75 of 77 · 1,532 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Guaifenesin and Pseudoephedrine Hydrochloride	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	PUBLIX SUPER MARKETS, INC	c857bcd9-6696-40d5-93c0-65097598cd4b	2022-04-08	Warnings	Exact identifier application number: ANDA212542 rxcui: 1305603 unii: 6V9V2RYJ8N unii: 495W7451VQ
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE	Proficient Rx LP	1b79a7d8-a8f4-4525-8b94-3e317fc5a717	2022-04-01	Warnings, Adverse reactions	Exact identifier unii: 6V9V2RYJ8N
Guaifenesin and Pseudoephedrine Hydrochloride	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	STRATEGIC SOURCING SERVICES LLC	d139fd8d-66fd-4484-8e78-ed90c505d999	2022-02-08	Warnings	Exact identifier application number: ANDA212542 ndc (package): 62011-0475-1 ndc (product): 62011-0475 ndc11 (package): 62011047501 rxcui: 1305603 spl id: 07be87a3-54dc-4ddb-bd01-45444b4cf0ac spl set id: d139fd8d-66fd-4484-8e78-ed90c505d999 unii: 6V9V2RYJ8N unii: 495W7451VQ
Ibuprofen and Pseudoephedrine HCl	IBUPROFEN AND PSEUDOEPHEDRINE HCL	Aurohealth LLC	6adf9292-b4af-4cb4-99f3-dda03734570a	2022-01-21	Warnings	Exact identifier unii: 6V9V2RYJ8N
basic care mucus dm	DEXTROMETHORPHAN HBR, GUAIFENESIN	Amazon.com Services LLC	ac01ad52-483a-4cce-9279-51ceecada9b9	2021-07-13	Warnings	Exact identifier unii: 495W7451VQ
Mucus Relief Immediate Release	GUAIFENESIN 400MG	Good Sense	e7c68746-7ec0-46cf-b4a3-174fab819b5e	2021-05-05	Warnings	Exact identifier unii: 495W7451VQ
Mucus Relief	GUAIFENESIN	Aphena Pharma Solutions - Tennessee, LLC	01af03f1-5d1b-4893-b7db-7092ba66e842	2021-05-03	Warnings	Exact identifier unii: 495W7451VQ
Mucus Relief Immediate Release	GUAIFENESIN 400MG	TopCo Associates, LLC	7d91c6ab-d161-42b9-b353-0aa8f59619f8	2021-01-21	Warnings	Exact identifier unii: 495W7451VQ
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	Proficient Rx LP	ed9399e2-2be8-4793-99c5-204779c2a471	2021-01-01	Warnings, Adverse reactions	Exact identifier unii: 6V9V2RYJ8N
Mucinex	GUAIFENESIN	Proficient Rx LP	f3ade814-2759-4ad0-a196-210e84d8cde9	2021-01-01	Warnings	Exact identifier unii: 495W7451VQ
Pseudoephedrine Hydrochloride	PSEUDOEPHEDRINE HYDROCHLORIDE	STRATEGIC SOURCING SERVICES LLC	918b2a90-532b-4358-bdff-9ad48c167a7e	2020-08-11	Warnings	Exact identifier unii: 6V9V2RYJ8N
nasal decongestant	PSEUDOEPHEDRINE HYDROCHLORIDE	Strategic Sourcing Services	53acd8d9-b9d8-4a38-8597-32043548d832	2020-07-01	Warnings	Exact identifier unii: 6V9V2RYJ8N
Allergy and Congestion	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI	Rite Aid Corporation	90e1aa06-b769-e8ac-af88-1d6a256b9487	2020-05-19	Warnings	Exact identifier unii: 6V9V2RYJ8N
Fexofenadine HCl and Pseudoephedrine HCI	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI	Dr. Reddy's Laboratories Inc.	6fd05737-d996-b5b6-dccf-bc179a9d606c	2019-09-09	Warnings	Exact identifier unii: 6V9V2RYJ8N
Pseudoephedrine Hydrochloride	PSEUDOEPHEDRINE HYDROCHLORIDE	HEB	d9b46ff2-8bde-47c0-bc63-b19dbe7e197b	2019-05-29	Warnings	Exact identifier unii: 6V9V2RYJ8N
12 Hour Nasal Decongestant	PSEUDOEPHEDRINE HYDROCHLORIDE	CVS Pharmacy	85955336-3f79-457d-822c-f8be019729d1	2019-05-23	Warnings	Exact identifier unii: 6V9V2RYJ8N
Pseudoephedrine Hydrochloride	PSEUDOEPHEDRINE HYDROCHLORIDE	CVS Pharmacy	3a3d11e5-ebbf-4356-8ae6-4e5656b5644c	2019-04-10	Warnings	Exact identifier unii: 6V9V2RYJ8N
Pseudoephedrine Hydrochloride	PSEUDOEPHEDRINE HYDROCHLORIDE	Chain Drug Consortium, LLC	aec6412a-b62c-44c8-84f5-77f5fa441028	2019-04-10	Warnings	Exact identifier unii: 6V9V2RYJ8N
Pseudoephedrine hydrochloride	PSEUDOEPHEDRINE HYDROCHLORIDE	SAM'S WEST INC	5a885a10-7751-44f1-b2d9-a918f27604df	2019-03-29	Warnings	Exact identifier unii: 6V9V2RYJ8N
Mucus Relief Immediate Release	GUAIFENESIN	Allegiant Health	221d64a2-b8c7-435a-aae4-fb58fd38108f	2019-03-26	Warnings	Exact identifier unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

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