Libera Tos

Product NDC: 60840-0300
11-digit product format: 608400300
Labeler code: 60840
Product ID: 60840-0300_49130127-464d-494f-3241-0bafe28af2df
Type: HUMAN OTC DRUG
Nonproprietary name: Dextromethorphan HBr, Guaifenesin
Dosage form: LIQUID
Route: ORAL
Labeler: RockHealth, Inc
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2013-11-01
Marketing end: 0000-00-00
Substance: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength: 5 mg/5mL; mg/5mL
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	60840-0300		I	Inactivated by FDA	2026-10-15
excluded package	package	60840-0300	60840-0300-1	I	Inactivated by FDA	2026-10-15
excluded package	package	60840-0300	60840-0300-2	I	Inactivated by FDA	2026-10-15

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 2 · 66 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	60840-0300-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	60840-0300-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	60840-0300-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	60840-0300-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	60840-0300-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	60840-0300-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	60840-0300-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	60840-0300-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	60840-0300-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	60840-0300-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	60840-0300-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	60840-0300-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	60840-0300-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	60840-0300-2	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	60840-0300-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	60840-0300-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	60840-0300-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	60840-0300-2	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	60840-0300-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	60840-0300-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	60840-0300-1	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	60840-0300-2	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	60840-0300-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	60840-0300-2	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	60840-0300-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	60840-0300-2	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	60840-0300-1	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	60840-0300-2	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	60840-0300-1	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	60840-0300-2	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	60840-0300-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	60840-0300-2	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	60840-0300-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	60840-0300-2	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	60840-0300-1	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	60840-0300-2	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	60840-0300-1	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	60840-0300-2	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	60840-0300-1	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	60840-0300-2	`e2bbac7714bc…`	`27bdfed8d636…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
60840-0300-1	2019-11-27	C162847	48780-1	9855e2a2-3fab-60a7-e053-dbdaa90a05bd	Libera Tos Children
60840-0300-2	2019-11-27	C162847	48780-1	9855e2a2-3fab-60a7-e053-dbdaa90a05bd	Libera Tos Children

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60840-0300-1	Libera Tos	118 mL in 1 BOTTLE	LIQUID	118		2
60840-0300-2	Libera Tos	178 mL in 1 BOTTLE	LIQUID	178		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	LIBERA TOS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ROCKHEALTH, INC]	2
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	LIBERA TOS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ROCKHEALTH, INC]	2
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	LIBERA TOS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ROCKHEALTH, INC]	2
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	LIBERA TOS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ROCKHEALTH, INC]	2
ALOE	INACTIVE INGREDIENT	V5VD430YW9	LIBERA TOS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ROCKHEALTH, INC]	2
CARAMEL	INACTIVE INGREDIENT	T9D99G2B1R	LIBERA TOS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ROCKHEALTH, INC]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	LIBERA TOS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ROCKHEALTH, INC]	2
EUCALYPTUS OIL	INACTIVE INGREDIENT	2R04ONI662	LIBERA TOS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ROCKHEALTH, INC]	2
GINGER	INACTIVE INGREDIENT	C5529G5JPQ	LIBERA TOS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ROCKHEALTH, INC]	2
HONEY	INACTIVE INGREDIENT	Y9H1V576FH	LIBERA TOS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ROCKHEALTH, INC]	2
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	INACTIVE INGREDIENT	8136Y38GY5	LIBERA TOS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ROCKHEALTH, INC]	2
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	LIBERA TOS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ROCKHEALTH, INC]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	LIBERA TOS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ROCKHEALTH, INC]	2
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	LIBERA TOS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ROCKHEALTH, INC]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	LIBERA TOS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ROCKHEALTH, INC]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	LIBERA TOS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ROCKHEALTH, INC]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	LIBERA TOS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ROCKHEALTH, INC]	2
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	LIBERA TOS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ROCKHEALTH, INC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	LIBERA TOS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ROCKHEALTH, INC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60840-0300	LIBERA TOS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ROCKHEALTH, INC]	2	Legacy NDC, 2 package rows	20131217_efae81ae-b70f-47c6-9d1d-3668d63dd5d1.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1482815	dextromethorphan HBr 5 MG / guaiFENesin 75 MG in 5 mL Oral Suspension	PSN	efae81ae-b70f-47c6-9d1d-3668d63dd5d1	2
1482815	dextromethorphan hydrobromide 1 MG/ML / guaifenesin 15 MG/ML Oral Suspension	SCD	efae81ae-b70f-47c6-9d1d-3668d63dd5d1	2
1482815	dextromethorphan hydrobromide 5 MG / guaifenesin 75 MG per 5 ML Oral Suspension	SY	efae81ae-b70f-47c6-9d1d-3668d63dd5d1	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
60840-0300-1	60840030001	118 mL in 1 BOTTLE	118 ml	Historical
60840-0300-2	60840030002	178 mL in 1 BOTTLE	178 ml	Historical