mucus D

Product NDC: 0113-8307
Requested package NDC: 0113-8307-68
11-digit product format: 001138307
Labeler code: 0113
Product ID: 0113-8307_db6ada8a-1799-4d35-8bda-4a322fbd7a06
Type: HUMAN OTC DRUG
Nonproprietary name: guaifenesin and pseudoephedrine hydrochloride
Dosage form: TABLET, MULTILAYER, EXTENDED RELEASE
Route: ORAL
Labeler: L. Perrigo Company
Application: ANDA214407
Marketing category: ANDA
Marketing start: 2025-10-03
Substance: GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength: 600; 60 mg/1; mg/1
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
A214407-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL			2022-02-01
A214407-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL			2022-02-01

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 2 · 68 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	A214407-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214407-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214407-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214407-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214407-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214407-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214407-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214407-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214407-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214407-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214407-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214407-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214407-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214407-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214407-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214407-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214407-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214407-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214407-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214407-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214407-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214407-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214407-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214407-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214407-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214407-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214407-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214407-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214407-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214407-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214407-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214407-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214407-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214407-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214407-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214407-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214407-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214407-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214407-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214407-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`bb7c543d1eb4…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: mucus D
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GUAIFENESIN	600 mg/1
PSEUDOEPHEDRINE HYDROCHLORIDE	60 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
495W7451VQ	Internal UNII lookup
6V9V2RYJ8N	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1305603	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
db6ada8a-1799-4d35-8bda-4a322fbd7a06	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66	Product name	1	20140508
70a83adc-6047-bbea-5a08-dfd304aa47d2	Product name	1	20140508
858ce051-9941-aafc-8c7c-44a8e0227463	Product name	1	20140508
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0113-8307-68	mucus D	18 in 1 BLISTER PACK	TABLET, MULTILAYER, EXTENDED REL	18		1
0113-8307-68	mucus D	2 in 1 CARTON	TABLET, MULTILAYER, EXTENDED REL	2		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0113-8307-68	EA - Each	0113-8307	d1a97d0e-ebc0-4b91-9506-a67bacab21d1	1	2026-01-08

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 1 of 1 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
foster and thrive mucus relief d	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	Strategic Sourcing Services LLC	12460719-ff39-49b3-95f8-85e547ad0076	2026-08-04	Warnings	Exact identifier application applno (ANDA): 214407 application number: ANDA214407
Leader Mucus Relief D	GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE	Cardinal Health 110, LLC. dba Leader	12971fb2-2314-4443-bf70-b7eb5859b148	2026-05-26	Warnings	Exact identifier application applno (ANDA): 214407 application number: ANDA214407
mucus d	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	Kroger Company	5065f07d-2130-4c84-a64a-dc27ef9cb92e	2026-04-09	Warnings	Exact identifier application applno (ANDA): 214407 application number: ANDA214407
nasal and chest decongestant	GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE	Publix Super Markets Inc	657aeccc-4f6a-496b-9a69-e64a81e4c91e	2026-04-02	Warnings	Exact identifier application applno (ANDA): 214407 application number: ANDA214407
equate mucus d	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	WALMART INC.	0d5f6e14-5e42-494b-be1f-a46731007a0d	2026-03-19	Warnings	Exact identifier application applno (ANDA): 214407 application number: ANDA214407
mucus d	GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	c8026a56-4249-48de-b763-2d1c55731733	2026-02-26	Warnings	Exact identifier application applno (ANDA): 214407 application number: ANDA214407
mucus relief d	GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE	Walgreen Company	440c0cf6-d63d-4523-b137-26f70adb977a	2026-02-07	Warnings	Exact identifier application applno (ANDA): 214407 application number: ANDA214407
foster and thrive mucus relief d	GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE	Strategic Sourcing Services LLC	235a465c-3a5e-4775-92e9-e57fd8d9c9b4	2026-02-07	Warnings	Exact identifier application applno (ANDA): 214407 application number: ANDA214407
mucus relief d	GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE	H E B	80acd350-7c96-4620-bd7c-848c85f157ed	2026-01-27	Warnings	Exact identifier application applno (ANDA): 214407 application number: ANDA214407
EQUATE MUCUS D	GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE	WALMART INC.	1ce50a5b-060d-4fb4-ba91-e62fccf9d5f9	2026-01-08	Warnings	Exact identifier application applno (ANDA): 214407 application number: ANDA214407
Mucus D	GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE	L. Perrigo Company	86993cd9-5d55-4a70-8a33-701d91482292	2025-10-03	Warnings	Exact identifier application applno (ANDA): 214407 application number: ANDA214407
mucus D	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	L. Perrigo Company	db6ada8a-1799-4d35-8bda-4a322fbd7a06	2025-10-03	Warnings	Exact identifier application applno (ANDA): 214407 application number: ANDA214407 ndc (package): 0113-8307-68 ndc (product): 0113-8307 ndc11 (package): 00113830768
mucus D	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	Meijer, Inc.	5d0c5ded-cf78-4c42-8dc0-8d546884871f	2025-06-10	Warnings	Exact identifier application applno (ANDA): 214407 application number: ANDA214407
topcare mucus d	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	Topco Associates LLC	02134afa-ae8c-4678-a19a-7fd3cab5782f	2023-08-30	Warnings	Exact identifier application applno (ANDA): 214407 application number: ANDA214407

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN
6V9V2RYJ8N	PSEUDOEPHEDRINE HYDROCHLORIDE	345-78-8	PSEUDOEPHEDRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1305603	guaiFENesin 600 MG / pseudoephedrine HCl 60 MG 12HR Extended Release Oral Tablet	PSN	db6ada8a-1799-4d35-8bda-4a322fbd7a06	1
1305603	12 HR guaifenesin 600 MG / pseudoephedrine hydrochloride 60 MG Extended Release Oral Tablet	SCD	db6ada8a-1799-4d35-8bda-4a322fbd7a06	1
1305603	guaifenesin 600 MG / pseudoephedrine hydrochloride 60 MG 12 HR Extended Release Oral Tablet	SY	db6ada8a-1799-4d35-8bda-4a322fbd7a06	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0113-8307-68	00113830768	2 BLISTER PACK in 1 CARTON (0113-8307-68) / 18 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK	2 blister pack	2025-10-03	No	No	Current