Guaiatussin AC

Product NDC: 50383-087
Requested package NDC: 50383-087-12
11-digit product format: 503830087
Labeler code: 50383
Product ID: 50383-087_487f1ce3-77d3-4390-ba6b-d9fed18c7f4d
Type: HUMAN OTC DRUG
Nonproprietary name: guaifenesin and codeine phosphate
Dosage form: LIQUID
Route: ORAL
Labeler: Akorn Operating Company LLC
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2010-09-08
Marketing end: 0000-00-00
Substance: CODEINE PHOSPHATE; GUAIFENESIN
Active strength: 10 mg/5mL; mg/5mL
Pharmacologic classes: Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Full Opioid Agonists [MoA], Increased Respiratory Secretions [PE], Opioid Agonist [EPC]
DEA schedule: CV
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50383-087	50383-087-12	I	Inactivated by FDA		2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
09d8330d-4fec-be98-3a66-f985140646b2	Product name	2	20210513
20c8cafe-5cfc-44f8-a9be-a664f437f780	Product name	2	20200225
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
c6fba691-a132-4ede-95c6-f8c6bd696636	Product name	1	20150902
c0200ab5-4954-454e-9676-30b741b245bd	Product name	1	20150730
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
e9576821-a971-5261-628e-82ad9e10acdb	Product name	2	20150121
2a21311a-89e2-0e83-2ebd-117f9798b2b2	Product name	1	20140508
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
47fd879b-91c5-e1e5-130f-29d082a871ec	Product name	1	20140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00	Product name	1	20140508
ce055423-1d7f-3c41-dff1-83660fa8cd96	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
50383-087-04	Drug Facts
50383-087-07	Drug Facts
50383-087-12	Drug Facts
50383-087-16	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50383-087-04	Guaiatussin ACSugar Free	118 mL in 1 BOTTLE	LIQUID	118	8
50383-087-05	Guaiatussin ACSugar Free	5 mL in 1 CUP, UNIT-DOSE	LIQUID	5	8
50383-087-07	Guaiatussin ACSugar Free	10 in 1 CASE	LIQUID	10	8
50383-087-07	Guaiatussin ACSugar Free	10 in 1 TRAY	LIQUID	10	8
50383-087-10	Guaiatussin ACSugar Free	10 mL in 1 CUP, UNIT-DOSE	LIQUID	10	8
50383-087-12	Guaiatussin ACSugar Free	10 in 1 TRAY	LIQUID	10	8
50383-087-12	Guaiatussin ACSugar Free	10 in 1 CASE	LIQUID	10	8
50383-087-16	Guaiatussin ACSugar Free	473 mL in 1 BOTTLE	LIQUID	473	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50383-087-04	ML - Milliliter	50383-087	29494081-d566-4f6d-8538-414cea304398	1	2012-07-24
50383-087-05	ML - Milliliter	50383-087	527380f2-ab5d-4c06-9067-7faccb7b4caf	1	2013-12-02
50383-087-07	ML - Milliliter	50383-087	41adca2b-ffe8-4268-9221-bbcfc9746c34	1	2013-12-02
50383-087-10	ML - Milliliter	50383-087	a0b09403-6e9e-405f-b8b2-1815a522ccc8	1	2013-12-02
50383-087-12	ML - Milliliter	50383-087	7ef59b38-bc41-4d6b-866a-eddac3fec541	1	2013-12-02
50383-087-16	ML - Milliliter	50383-087	916d3d41-fe50-4fdf-bcd2-173e682bfafe	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CODEINE PHOSPHATE	ACTIVE INGREDIENT	GSL05Y1MN6	GUAIATUSSIN AC (GUAIFENESIN AND CODEINE PHOSPHATE) LIQUID [HI-TECH PHARMACAL CO., INC.]	4
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	GUAIATUSSIN AC (GUAIFENESIN AND CODEINE PHOSPHATE) LIQUID [HI-TECH PHARMACAL CO., INC.]	4
CODEINE ANHYDROUS	ACTIVE MOIETY	UX6OWY2V7J	GUAIATUSSIN AC (GUAIFENESIN AND CODEINE PHOSPHATE) LIQUID [HI-TECH PHARMACAL CO., INC.]	4
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	GUAIATUSSIN AC (GUAIFENESIN AND CODEINE PHOSPHATE) LIQUID [HI-TECH PHARMACAL CO., INC.]	4
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	GUAIATUSSIN AC (GUAIFENESIN AND CODEINE PHOSPHATE) LIQUID [HI-TECH PHARMACAL CO., INC.]	4
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	GUAIATUSSIN AC (GUAIFENESIN AND CODEINE PHOSPHATE) LIQUID [HI-TECH PHARMACAL CO., INC.]	4
CARAMEL	INACTIVE INGREDIENT	T9D99G2B1R	GUAIATUSSIN AC (GUAIFENESIN AND CODEINE PHOSPHATE) LIQUID [HI-TECH PHARMACAL CO., INC.]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	GUAIATUSSIN AC (GUAIFENESIN AND CODEINE PHOSPHATE) LIQUID [HI-TECH PHARMACAL CO., INC.]	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	GUAIATUSSIN AC (GUAIFENESIN AND CODEINE PHOSPHATE) LIQUID [HI-TECH PHARMACAL CO., INC.]	4
POLYETHYLENE GLYCOL 4000	INACTIVE INGREDIENT	4R4HFI6D95	GUAIATUSSIN AC (GUAIFENESIN AND CODEINE PHOSPHATE) LIQUID [HI-TECH PHARMACAL CO., INC.]	4
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	GUAIATUSSIN AC (GUAIFENESIN AND CODEINE PHOSPHATE) LIQUID [HI-TECH PHARMACAL CO., INC.]	4
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	GUAIATUSSIN AC (GUAIFENESIN AND CODEINE PHOSPHATE) LIQUID [HI-TECH PHARMACAL CO., INC.]	4
SORBITOL	INACTIVE INGREDIENT	506T60A25R	GUAIATUSSIN AC (GUAIFENESIN AND CODEINE PHOSPHATE) LIQUID [HI-TECH PHARMACAL CO., INC.]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	GUAIATUSSIN AC (GUAIFENESIN AND CODEINE PHOSPHATE) LIQUID [HI-TECH PHARMACAL CO., INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50383-087	GUAIATUSSIN AC SUGAR FREE (GUAIFENESIN AND CODEINE PHOSPHATE) LIQUID [AKORN OPERATING COMPANY LLC]	8	Legacy NDC, 8 package rows	20221018_b920eba2-27f2-402c-a7c9-d0988977965c.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
GSL05Y1MN6	CODEINE PHOSPHATE	41444-62-6	CODEINE PHOSPHATE
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
995868	codeine phosphate 10 MG / guaiFENesin 100 MG in 5 mL Oral Solution	PSN	b920eba2-27f2-402c-a7c9-d0988977965c	8
995868	codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	b920eba2-27f2-402c-a7c9-d0988977965c	8
995868	codeine phosphate 10 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	b920eba2-27f2-402c-a7c9-d0988977965c	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50383-087-12	50383008712	10 TRAY in 1 CASE (50383-087-12) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (50383-087-10)	10 tray	2010-09-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Cardinal Health 107, LLC	2023-11-15	HUMAN OTC DRUG LABEL	2
Drug Facts	A-S Medication Solutions	2023-02-04	HUMAN OTC DRUG LABEL	14
Drug Facts	Akorn Operating Company LLC	2022-10-14	HUMAN OTC DRUG LABEL	8
Drug Facts	Preferred Pharmaceuticals, Inc.	2020-06-08	HUMAN OTC DRUG LABEL	2