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 73 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	Marc Glassman, Inc.	e916ef86-ca73-42dd-83dc-6033f56d96f2	2025-12-19	Warnings	Exact identifier application number: M012
Original Night-Time MULTI-SYMPTOM COLD/FLU RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Discount Drug Mart	e243033b-6603-4c3e-a330-e7c7de51f69d	2025-12-19	Warnings	Exact identifier application number: M012
CHILDRENS ALLERGY	DIPHENHYDRAMINE HYDROCHLORIDE	Discount Drug Mart	6fa4f913-de83-4175-9dad-0dedab5b69a1	2025-12-19	Warnings	Exact identifier application number: M012
Day-Time COLD/FLU RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL	Discount Drug Mart	426db906-9aa4-448f-a361-09c1516efc25	2025-12-19	Warnings	Exact identifier application number: M012
MAXIUM STRENGTH SEVERE CONGESTION and COUGH MAX	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Discount Drug Mart	f17385bc-82bb-4183-a4c9-067d8afb3757	2025-12-19	Warnings	Exact identifier application number: M012
MAXIUM STRENGTH DM MAX	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Discount Drug Mart	9654fdcd-d660-471f-bc5d-aa7dead7a4a8	2025-12-19	Warnings	Exact identifier application number: M012
Night Time Multi-Symptom Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Discount Drug Mart	8148c2b1-f6ec-4597-8e18-a6597cda5705	2025-12-19	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL 25 MG	NUVICARE LLC	621ba20e-75c5-42fb-9692-7800f764c978	2025-12-19	Warnings	Exact identifier application number: M012
Nasal Decongestant PE	PHENYLEPHRINE HCL 10 MG	NUVICARE LLC	4cde41dd-a0a7-45e7-aff3-ee9402dfdff2	2025-12-19	Warnings	Exact identifier application number: M012
COMBINATION PACK TopCare health DayTime SEVERE and NiteTime SEVERE Cold and Flu Relief SOFTGELS - 24 ct	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	ceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e	2025-12-19	Warnings	Exact identifier application number: M012
NeoTuss S/F Grape-Menthol Flavor	GUAIFENESIN, DEXTROMETHORPHAN HBR	DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals	2f3df82c-1926-5238-e063-6294a90a7bbf	2025-12-18	Warnings	Exact identifier application number: M012
NeoTuss S/F Grape-Menthol Flavor	GUAIFENESIN, DEXTROMETHORPHAN HBR	DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals	2fac3425-32f0-38d6-e063-6394a90a6e7a	2025-12-18	Warnings	Exact identifier application number: M012
NAFASOLINA	NAPHAZOLINE HYDROCHLORIDE	Doral Pharmamedics Inc DBA AG Marin Pharmaceuticals	30cade3d-208f-8594-e063-6394a90ad2a0	2025-12-18	Warnings	Exact identifier application number: M012
Honey Lemon Flavor Cough Drop	HONEY LEMON FLAVOR COUGH DROP	Army & Air Force Exchange Service	20ac8a20-206c-0024-e063-6394a90a9d06	2025-12-18	Warnings	Exact identifier application number: M012
Menthol Flavor Cough Drop	MENTHOL FLAVOR COUGH DROP	Army & Air Force Exchange Service	20ace10f-4257-b20e-e063-6394a90a3c7b	2025-12-18	Warnings	Exact identifier application number: M012
NeoTuss Plus	DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals	2fabd782-14dc-1d1b-e063-6394a90af428	2025-12-18	Warnings	Exact identifier application number: M012
NeoTuss Plus	DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals	2f3c6b38-7236-899b-e063-6294a90aabde	2025-12-18	Warnings	Exact identifier application number: M012
QUALITY CHOICE Cough Drops Black Cherry SUGAR FREE	MENTHOL	Chain Drug Marketing Association, Inc.	8f6ee01c-baad-489f-b2fd-0ef506916ee4	2025-12-18	Warnings	Exact identifier application number: M012
menthol cough drops	MENTHOL	Meijer	5baeaff7-172c-187a-e053-2a91aa0ab165	2025-12-18	Warnings	Exact identifier application number: M012
Menthol Cough Drops	MENTHOL	Meijer Distribution Inc.	3bee752a-4141-1f5b-e054-00144ff8d46c	2025-12-18	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