caring mill mucus dm

Product NDC: 81522-812
11-digit product format: 815220812
Labeler code: 81522
Product ID: 81522-812_34efe9f6-c515-4283-8c2f-ef506bb2eed6
Type: HUMAN OTC DRUG
Nonproprietary name: dextromethorphan HBr, guaifenesin
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: FSA Store Inc.
Application: ANDA207602
Marketing category: ANDA
Marketing start: 2021-11-10
Marketing end: 0000-00-00
Substance: GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength: 1200 mg/1; mg/1
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	81522-812		D	Discontinued by firm		2026-10-05
excluded package	package	81522-812	81522-812-66	D	Discontinued by firm		2026-10-05

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207602-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL			2018-03-05
A207602-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL			2018-03-05

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A207602-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207602-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207602-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207602-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207602-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207602-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207602-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207602-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207602-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207602-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207602-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207602-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207602-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207602-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207602-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207602-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207602-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207602-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207602-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207602-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207602-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207602-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207602-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207602-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207602-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207602-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207602-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207602-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207602-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207602-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207602-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207602-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207602-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207602-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207602-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207602-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207602-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207602-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207602-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207602-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81522-812	CARING MILL MUCUS DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) TABLET, EXTENDED RELEASE [FSA STORE INC.]	2	Legacy NDC	20211209_814bc1e4-85a0-4aa7-baa9-b9636fa38473.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 2 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GOOD SENSE MUCUS DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	A-S Medication Solutions	9995f480-da71-4e3b-8154-9eefaeb9299d	2024-09-26	Warnings	Exact identifier application applno (ANDA): 207602 application number: ANDA207602
Robitussin Maximum Strength 12 Hour Cough and Mucus Relief	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Haleon US Holdings LLC	96409b52-b0ec-444b-bc39-fd41070e9855	2024-04-07	Warnings	Exact identifier application applno (ANDA): 207602 application number: ANDA207602
equaline mucus dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	United Natural Foods, Inc. dba UNFI	1db69578-2331-4fce-91a4-95c54cb7dc07	2023-08-07	Warnings	Exact identifier application applno (ANDA): 207602 application number: ANDA207602
Equaline Mucus DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	United Natural Foods, Inc. dba UNFI	04334889-f75e-4a19-a8b4-47b8db18b9aa	2023-08-02	Warnings	Exact identifier application applno (ANDA): 207602 application number: ANDA207602
DG health mucus dm	DEXTROMETHORPHAN HBR, GUAIFENESIN	Dolgencorp, LLC	add72ca5-94cd-437f-b30f-6149c08b5f21	2022-11-14	Warnings	Exact identifier application applno (ANDA): 207602 application number: ANDA207602
basic care mucus dm	DEXTROMETHORPHAN HBR, GUAIFENESIN	Amazon.com Services LLC	ac01ad52-483a-4cce-9279-51ceecada9b9	2021-07-13	Warnings	Exact identifier application applno (ANDA): 207602 application number: ANDA207602

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
81522-812-66	81522081266	1 BOTTLE in 1 CARTON (81522-812-66) > 14 TABLET, EXTENDED RELEASE in 1 BOTTLE	1 bottle	2021-11-10	0000-00-00	No	No	Current