Childrens Chest Congestion Relief Grape

Product NDC: 53943-511
11-digit product format: 539430511
Labeler code: 53943
Product ID: 53943-511_821e5d82-0d59-4c10-bd7c-1064a55d6270
Type: HUMAN OTC DRUG
Nonproprietary name: GUAIFENESIN
Dosage form: LIQUID
Route: ORAL
Labeler: Discount Drug Mart
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-02-04
Substance: GUAIFENESIN
Active strength: 100 mg/5mL
Pharmacologic classes: Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 4 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
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	53943-511-24	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53943-511-24	`9bebd1f3094a…`	`5416666fcb17…`

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: Childrens Chest Congestion Relief Grape
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GUAIFENESIN	100 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310604	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
3e5d245f-515c-4106-a855-fb97681b646a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53943-511-24	2020-12-31	C162847	48780-1	9d75b9d0-74dd-f424-e053-dadaa90a57ce	3e5d245f-515c-4106-a855-fb97681b646a
53943-511-24	2020-01-31	C162847	48780-1	9d75b9d0-74dd-f424-e053-dadaa90a57ce	3e5d245f-515c-4106-a855-fb97681b646a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53943-511-24	Childrens Chest Congestion Relief Grape	118 mL in 1 BOTTLE	LIQUID	118		6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	CHILDRENS CHEST CONGESTION RELIEF GRAPE (GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]	1
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	CHILDRENS CHEST CONGESTION RELIEF GRAPE (GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	CHILDRENS CHEST CONGESTION RELIEF GRAPE (GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]	1
DEXTROSE	INACTIVE INGREDIENT	IY9XDZ35W2	CHILDRENS CHEST CONGESTION RELIEF GRAPE (GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CHILDRENS CHEST CONGESTION RELIEF GRAPE (GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CHILDRENS CHEST CONGESTION RELIEF GRAPE (GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CHILDRENS CHEST CONGESTION RELIEF GRAPE (GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]	1
MALTITOL	INACTIVE INGREDIENT	D65DG142WK	CHILDRENS CHEST CONGESTION RELIEF GRAPE (GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CHILDRENS CHEST CONGESTION RELIEF GRAPE (GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	CHILDRENS CHEST CONGESTION RELIEF GRAPE (GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	CHILDRENS CHEST CONGESTION RELIEF GRAPE (GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	CHILDRENS CHEST CONGESTION RELIEF GRAPE (GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	CHILDRENS CHEST CONGESTION RELIEF GRAPE (GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	CHILDRENS CHEST CONGESTION RELIEF GRAPE (GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53943-511	CHILDRENS CHEST CONGESTION RELIEF GRAPE (GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]	5	Current NDC, Legacy NDC, 1 package rows	20241222_3e5d245f-515c-4106-a855-fb97681b646a.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 64 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dologesic DF	ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE	Llorens Pharmaceutical International Division	55768b45-fd98-4779-85b6-6a50c628677e	2025-12-31	Warnings	Exact identifier application number: M012
Triponel	DEXTROMETHORPHAN HBR, PSEUFOEPHEDRINE HCL, TRIPROLIDINE HCL	Llorens Pharmaceutical International Division, Inc.	e9a8deb4-0595-4f0f-ac15-f936f15aca88	2025-12-31	Warnings	Exact identifier application number: M012
Tusnel	DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL	Llorens Pharmaceutical International Division	805dc611-355a-4af5-bf19-464c3290c5c6	2025-12-31	Warnings	Exact identifier application number: M012
Tusnel Pediatric	DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL	Llorens Pharmaceutical International Division	82f447f6-4f1b-4f56-9d7d-ea02adeea88c	2025-12-31	Warnings	Exact identifier application number: M012
Triponel	DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCL	LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION	cc774d33-96ce-4992-ad30-3cb03b0d119d	2025-12-31	Warnings	Exact identifier application number: M012
Tusnel SF	DEXTROMETHORPHAN HBR, GUAIFENESIN	Llorens Pharmaceutical International Division, Inc.	cb43b4df-5ccc-416e-abcd-98f079b3f2bb	2025-12-31	Warnings	Exact identifier application number: M012
Tusnel Cough Suppressant Expectorant	DEXTROMETHORPHAN HBR, GUAIFENESIN	Llorens Pharmaceutical International Division, Inc.	af71cdbc-33d6-4303-b494-d7321721d3be	2025-12-31	Warnings	Exact identifier application number: M012
Tusnel Pediatric DM	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Llorens Pharmaceutical International Division, Inc.	63541753-de8d-42fe-a9b3-a5eac3fcdca4	2025-12-31	Warnings	Exact identifier application number: M012
Tusnel Pediatric Drops	GUAIFENESIN, PHENYLEPHRINE HCL	LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION	dbf7c43a-7b29-4c70-9e6d-8a7ea924a9d7	2025-12-31	Warnings	Exact identifier application number: M012
Tusnel DM Pediatric	DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL	Llorens Pharmaceutical International Division	d915eab8-013e-4ce3-b358-0d531e5ca1ba	2025-12-31	Warnings	Exact identifier application number: M012
Tusnel-DM Pediatric	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION	64e36b02-b5be-4d20-8818-cb5b23596671	2025-12-31	Warnings	Exact identifier application number: M012
Honey Lemon Cough Drops	MENTHOL	Bestco Inc.	77f89a64-f4a4-f909-e053-2a91aa0ad44d	2025-12-31	Warnings	Exact identifier application number: M012
Honey Lemon Cough Drops	MENTHOL	Bestco Inc.	77f65f59-7ea1-adce-e053-2991aa0a6f1f	2025-12-31	Warnings	Exact identifier application number: M012
Sugar Free Honey Lemon Cough Drops	MENTHOL	Bestco Inc.	77f9e176-d87a-beed-e053-2991aa0aac20	2025-12-31	Warnings	Exact identifier application number: M012
Sugar Free Cherry Cough Drops	MENTHOL	Bestco Inc.	7858f380-bef7-3d30-e053-2a91aa0a7ea6	2025-12-31	Warnings	Exact identifier application number: M012
Strawberry Cough Drops	MENTHOL	BestCo Inc.	26a22cfd-395b-4ffb-e054-00144ff88e88	2025-12-31	Warnings	Exact identifier application number: M012
Limpia Pecho	DEXTROMETHORPHAN HBR, GUAIFENESIN	Llorens Pharmaceutical International Division, Inc.	cbaea3e4-4c4b-4ff9-ae6f-95b6a2d3faf3	2025-12-31	Warnings	Exact identifier application number: M012
Cherry Sore Throat Lozenges	BENZOCAINE	Bestco Inc.	737efd41-2d59-6013-e053-2a91aa0a6c63	2025-12-31	Warnings	Exact identifier application number: M012
Best Health Menthol Cough Drops	MENTHOL	Bestco LLC	dda66a3c-9006-ff1a-e053-2a95a90abfb3	2025-12-31	Warnings	Exact identifier application number: M012
Rynex DM	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Edwards Pharmaceuticals, Inc	7be2c282-24ba-4f19-9b14-872d3f5746a7	2025-12-31	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310604	guaiFENesin 100 MG in 5 mL Oral Solution	PSN	3e5d245f-515c-4106-a855-fb97681b646a	6
310604	guaifenesin 20 MG/ML Oral Solution	SCD	3e5d245f-515c-4106-a855-fb97681b646a	6
310604	guaifenesin 100 MG per 5 ML Oral Solution	SY	3e5d245f-515c-4106-a855-fb97681b646a	6
310604	guaifenesin 100 MG per 5 ML Oral Syrup	SY	3e5d245f-515c-4106-a855-fb97681b646a	6
310604	guaifenesin 200 MG per 10 ML Oral Solution	SY	3e5d245f-515c-4106-a855-fb97681b646a	6
310604	guaifenesin 300 MG per 15 ML Oral Solution	SY	3e5d245f-515c-4106-a855-fb97681b646a	6
310604	guaifenesin 400 MG per 20 ML Oral Solution	SY	3e5d245f-515c-4106-a855-fb97681b646a	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53943-511-24	53943051124	118 mL in 1 BOTTLE (53943-511-24)	118 ml	2015-02-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Childrens Chest Congestion Relief Grape - Discount Drug Mart	Discount Drug Mart	2025-12-23	HUMAN OTC DRUG LABEL	6