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 162 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE	Kroger	1013ce02-7b12-335e-e063-6394a90af3e6	2024-05-08	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE	Kroger	10b08ea8-693e-eb18-e063-6394a90af548	2024-05-08	Warnings	Exact identifier application number: M012
Nighttime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Kroger	10b0bcff-d3bc-f70c-e063-6394a90a35ed	2024-05-08	Warnings	Exact identifier application number: M012
Daytime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Kroger	10b0e0a0-b878-0a9a-e063-6394a90a20e0	2024-05-08	Warnings	Exact identifier application number: M012
Severe Cold and Flu Daytime Honey	ACETAMINOPHEN, DEXTROMETHROPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Kroger	10b0fa3d-d6b2-272a-e063-6394a90a1205	2024-05-08	Warnings	Exact identifier application number: M012
Childrens Plus Multi Symptom Cold	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Walgreens	dd967cfb-96b4-4cdc-82e2-a4838001c9e3	2024-05-08	Warnings	Exact identifier application number: M012
Childrens Wal Tap Elixer Cold and Allergy	BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Walgreens	3f438f28-d1ad-44da-a573-f1b0824b051c	2024-05-08	Warnings	Exact identifier application number: M012
Cough Cold and Sore Throat Childrens	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreens	400a0998-e276-4c8d-9b41-145b1b405fff	2024-05-08	Warnings	Exact identifier application number: M012
Mucus Congestion and Cough Relief Childrens	DEXTROMETHORPHAN HBR, GUAIFENSIN, PHENYLEPHRINE HCI	Walgreens	19cd2409-d56b-4319-833c-eacc7dc498c1	2024-05-08	Warnings	Exact identifier application number: M012
Severe Cold and Flu Nighttime Honey	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Kroger	10b12f0e-dba7-fd71-e063-6294a90a42c1	2024-05-06	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DEXTROMETHORPHAN HBRDOXYLAMINE SUCCINATE	Kroger	10b15337-b9c5-4dc8-e063-6394a90ac056	2024-05-06	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Kroger	1014da86-3a0e-136f-e063-6294a90ac931	2024-05-04	Warnings	Exact identifier application number: M012
Robitussin Honey Maximum Strength Cough and Chest Congestion DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Haleon US Holdings LLC	eaa10aed-5b1e-48bf-bc05-7a5638851daf	2024-05-03	Warnings	Exact identifier application number: M012
Theraflu-D Flu Relief Max Strength plus Nasal Decongestant	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCL	Haleon US Holdings LLC	e35cb719-9e7d-4b2b-81a4-29e147dd74fa	2024-05-03	Warnings	Exact identifier application number: M012
Theraflu-D Flu Relief Max Strength plus Nasal Decongestant Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCL	Haleon US Holdings LLC	09e20842-2b75-43b9-ae5f-3515b35e655b	2024-05-03	Warnings	Exact identifier application number: M012
Cold and Flu Relief	ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL	Family Dollar (FAMILY WELLNESS)	f958d8ba-ede9-4b1a-8317-2404b68a9129	2024-05-03	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold and Flu Relief Multi-Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	WinCo Foods, LLC	fab57d70-ba54-416f-9f14-b64d2238ea16	2024-05-03	Warnings	Exact identifier application number: M012
Tussin CF Non Drowsy Multi Symptom	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	WinCo Foods, LLC	8ee27600-4f8e-406a-8ea3-eade691448f6	2024-05-03	Warnings	Exact identifier application number: M012
SanaTos Children Cough and Congestion Cherry	DEXTROMETHORPHAN HBR AND GUAIFENESIN	Pharmadel LLC	60437d86-9e13-8d8a-e053-2991aa0a2317	2024-05-02	Warnings	Exact identifier application number: M012
Robitussin Honey Maximum Strength Nighttime Cough DM	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Haleon US Holdings LLC	0b41da13-18a1-4987-ae43-1319bfa27484	2024-05-01	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