NDC 11523-0122-01 - MiraLAX Orange Flavor

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: 11523-0122
Requested NDC: 11523-0122-01
Package NDCs from labels: 11523-0122-2, 11523-0122-1, 11523-0122-01
Manufacturer: Bayer HealthCare LLC.
Effective date: 2025-12-04
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
MiraLAX ® Orange Flavor	Bayer HealthCare LLC.	2025-12-04	HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
11523-0122-1	MiraLAX Orange Flavor	238 g in 1 BOTTLE	POWDER, FOR SOLUTION	238		3
11523-0122-2	MiraLAX Orange Flavor	119 g in 1 BOTTLE	POWDER, FOR SOLUTION	119		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11523-0122	MIRALAX ORANGE FLAVOR (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [BAYER HEALTHCARE LLC.]	2	Current NDC, 2 package rows	20241208_0a5b2121-928f-8f49-e063-6394a90a8aaf.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 6 of 6 · 107 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Equate ClearLAX	POLYETHYLENE GLYCOL 3350	WALMART INC.	c5c13378-3c08-415f-8ab4-8a18d6300ca8	2022-09-08	Warnings	Exact identifier application number: ANDA090685 rxcui: 876193 unii: G2M7P15E5P
injoy constipation relief	POLYETHYLENE GLYCOL 3350	L. Perrigo Company	b2414517-04bf-4f29-951e-b867855078c3	2022-08-19	Warnings	Exact identifier application number: ANDA090685 rxcui: 876193 unii: G2M7P15E5P
Good Sense Clear Lax	POLYETHYLENE GLYCOL 3350	Proficient Rx LP	0858a914-4812-4e4d-82f8-ecf93d43ef3b	2022-07-01	Warnings	Exact identifier application number: ANDA090685 unii: G2M7P15E5P
GAVILAX	POLYETHYLENE GLYCOL 3350	Proficient Rx LP	199d6173-3fad-49e4-88fe-bde7223ed4c3	2022-06-01	Warnings	Exact identifier rxcui: 876193 unii: G2M7P15E5P
Polyethylene Glycol	POLYETHYLENE GLYCOL	BluePoint Laboratories	c4cae70c-68da-0bbc-e053-2a95a90a395a	2021-09-20	Warnings	Exact identifier unii: G2M7P15E5P
signature care clearlax	POLYETHYLENE GLYCOL 3350	Safeway	91d2e780-2aae-411c-b7b3-820302f0f63e	2021-05-13	Warnings	Exact identifier application number: ANDA090685 rxcui: 876193 unii: G2M7P15E5P
POLYETHYLENE GLYCOL 3350 NF	POLYETHYLENE GLYCOL 3350	SUNRISE PHARMACEUTICAL, INC	ce5197a1-2677-4ffb-aef2-9221b28ebd23	2020-01-22	Warnings	Exact identifier rxcui: 876193 unii: G2M7P15E5P

Reported adverse events (FAERS/openFDA)#

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