Daytime Severe Cold and Flu Relief

Product NDC: 11822-0710
11-digit product format: 118220710
Labeler code: 11822
Product ID: 11822-0710_2fb0c9bd-f01d-4f11-9078-5dbaa43f4026
Type: HUMAN OTC DRUG
Nonproprietary name: acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
Dosage form: SOLUTION
Route: ORAL
Labeler: Rite Aid Corporation
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-06-18
Marketing end: 2026-12-31
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag: No
Current FDA listing: Yes

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: Daytime Severe Cold and Flu Relief

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	325 mg/15mL
DEXTROMETHORPHAN HYDROBROMIDE	10 mg/15mL
GUAIFENESIN	200 mg/15mL
PHENYLEPHRINE HYDROCHLORIDE	5 mg/15mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup
9D2RTI9KYH	Internal UNII lookup
495W7451VQ	Internal UNII lookup
04JA59TNSJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1369842	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
8d41defe-8120-4cbb-b42e-c805cc5a794b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
f4368033-af8c-41bf-a84b-ff77392b8522	Product name	1	20161229
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
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
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
11822-0710-1	Daytime Severe Cold and Flu Relief	355 mL in 1 BOTTLE	SOLUTION	355		6
11822-0710-1	daytime nighttime severe cold and flu relief	355 mL in 1 BOTTLE	SOLUTION	355 mL	5 mg in 15mL	4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	DAYTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [RITE AID CORPORATION]	2
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	DAYTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [RITE AID CORPORATION]	2
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	DAYTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [RITE AID CORPORATION]	2
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	DAYTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [RITE AID CORPORATION]	2
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	DAYTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [RITE AID CORPORATION]	2
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	DAYTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [RITE AID CORPORATION]	2
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	DAYTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [RITE AID CORPORATION]	2
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	DAYTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [RITE AID CORPORATION]	2
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	DAYTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [RITE AID CORPORATION]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	DAYTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [RITE AID CORPORATION]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DAYTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [RITE AID CORPORATION]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	DAYTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [RITE AID CORPORATION]	2
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	DAYTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [RITE AID CORPORATION]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DAYTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [RITE AID CORPORATION]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DAYTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [RITE AID CORPORATION]	2
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	DAYTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [RITE AID CORPORATION]	2
SODIUM PHOSPHATE, MONOBASIC	INACTIVE INGREDIENT	3980JIH2SW	DAYTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [RITE AID CORPORATION]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DAYTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [RITE AID CORPORATION]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	DAYTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [RITE AID CORPORATION]	2
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	DAYTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [RITE AID CORPORATION]	2
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	DAYTIME NIGHTTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [RITE AID CORPORATION]	1
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	DAYTIME NIGHTTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [RITE AID CORPORATION]	1
DOXYLAMINE SUCCINATE	ACTIVE INGREDIENT	V9BI9B5YI2	DAYTIME NIGHTTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [RITE AID CORPORATION]	1
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	DAYTIME NIGHTTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [RITE AID CORPORATION]	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	DAYTIME NIGHTTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [RITE AID CORPORATION]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	DAYTIME NIGHTTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [RITE AID CORPORATION]	1
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	DAYTIME NIGHTTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [RITE AID CORPORATION]	1
DOXYLAMINE	ACTIVE MOIETY	95QB77JKPL	DAYTIME NIGHTTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [RITE AID CORPORATION]	1
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	DAYTIME NIGHTTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [RITE AID CORPORATION]	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	DAYTIME NIGHTTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [RITE AID CORPORATION]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	DAYTIME NIGHTTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [RITE AID CORPORATION]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	DAYTIME NIGHTTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [RITE AID CORPORATION]	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	DAYTIME NIGHTTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [RITE AID CORPORATION]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DAYTIME NIGHTTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [RITE AID CORPORATION]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	DAYTIME NIGHTTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [RITE AID CORPORATION]	1
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	DAYTIME NIGHTTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [RITE AID CORPORATION]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DAYTIME NIGHTTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [RITE AID CORPORATION]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	DAYTIME NIGHTTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [RITE AID CORPORATION]	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	DAYTIME NIGHTTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [RITE AID CORPORATION]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DAYTIME NIGHTTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [RITE AID CORPORATION]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DAYTIME NIGHTTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [RITE AID CORPORATION]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	DAYTIME NIGHTTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [RITE AID CORPORATION]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	DAYTIME NIGHTTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [RITE AID CORPORATION]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	DAYTIME NIGHTTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [RITE AID CORPORATION]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	DAYTIME NIGHTTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [RITE AID CORPORATION]	1
SODIUM PHOSPHATE, MONOBASIC	INACTIVE INGREDIENT	3980JIH2SW	DAYTIME NIGHTTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [RITE AID CORPORATION]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	DAYTIME NIGHTTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [RITE AID CORPORATION]	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	DAYTIME NIGHTTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [RITE AID CORPORATION]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DAYTIME NIGHTTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [RITE AID CORPORATION]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	DAYTIME NIGHTTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [RITE AID CORPORATION]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	DAYTIME NIGHTTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [RITE AID CORPORATION]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11822-0710	DAYTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [RITE AID CORPORATION]	6	Current NDC, Legacy NDC, 1 package rows	20241030_8d41defe-8120-4cbb-b42e-c805cc5a794b.zip
11822-0710	DAYTIME NIGHTTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [RITE AID CORPORATION]	4	Current NDC, Legacy NDC	20241116_eb58871d-f351-47a1-aeab-254ec6693ddd.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 100 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MGC Health Cough Drops Honey Herb	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	3fa17272-fd7f-9ab4-e063-6394a90a585f	2025-09-25	Warnings	Exact identifier application number: M012
MGC Health Throat Soothing Drops Creamy Strawberry	PECTIN	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	3fa2e438-2ff3-a2df-e063-6394a90ac7b5	2025-09-25	Warnings	Exact identifier application number: M012
QUALITY CHOICE ADULT TUSSIN EXPECTORANT	GUAIFENESIN	QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)	63dad603-fe2f-42a6-a626-5c8048a42c10	2025-09-25	Warnings	Exact identifier application number: M012
Giltuss Childrens Allergy Plus	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Dextrum Laboratories Inc.	3fa5220f-38bb-9ef6-e063-6294a90aeff8	2025-09-25	Warnings	Exact identifier application number: M012
Acetaminophen 325 mg, Dextromethorphan Hydrobromide 10 mg, Phenlyephrine Hydrochloride 5 mg softgel (DAY-TIME)	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Health Pharma USA LLC	a03befb4-d86d-43e4-8097-eda5c8bb25be	2025-09-24	Warnings	Exact identifier application number: M012
Childrens Giltuss EX Expectorant	GUAIFENESIN	Dextrum Laboratories Inc.	3f8d7d47-f14c-888c-e063-6394a90a5cdd	2025-09-24	Warnings	Exact identifier application number: M012
Childrens Giltuss Honey Cough and Chest Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	Dextrum Laboratories, Inc	3f909bc2-eb84-a19d-e063-6294a90ae04e	2025-09-24	Warnings	Exact identifier application number: M012
Giltuss Honey DM Cough	DEXTROMETHORPHAN HBR	Dextrum Laboratories, Inc	3f79137f-f0b0-d22c-e063-6394a90a7245	2025-09-23	Warnings	Exact identifier application number: M012
GoodSense Medicated Chest Rub	CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL	GOOD SENSE	240bb6af-9d38-49fe-9011-3016246b0986	2025-09-23	Warnings	Exact identifier application number: M012
Xpect Honey Lemon Cough Drops	HONEY LEMON COUGH DROPS	Cintas Corporation	79e0b7c1-4acc-41d2-89cd-d075a8bac0c9	2025-09-23	Warnings	Exact identifier application number: M012
Topcare NiteTime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Topco Associates LLC	b2b3c450-e988-41d1-9e53-cc8e30d75cb4	2025-09-23	Warnings	Exact identifier application number: M012
Xpect Cherry Cough Drops	CHERRY COUGH DROPS	Cintas Corporation	d1fd2f23-5435-405d-a7fd-644691f79e80	2025-09-23	Warnings	Exact identifier application number: M012
Topcare DayTime NiteTime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Topco Associates LLC	560fb22b-391f-4d7b-a6fd-38d577d404b0	2025-09-23	Warnings	Exact identifier application number: M012
Giltuss EX Expectorant	GUAIFENESIN	Dextrum Laboratories Inc.	3f67ac3d-1503-3418-e063-6394a90a938f	2025-09-22	Warnings	Exact identifier application number: M012
Giltuss HBP Cough and Chest Congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Dextrum Laboratories Inc.	3f68e68a-cf32-9df8-e063-6394a90a3012	2025-09-22	Warnings	Exact identifier application number: M012
SUPRESS A	DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Kramer Novis	f0bec5f5-4d76-471e-9024-557eba848b93	2025-09-22	Warnings	Exact identifier application number: M012
RIGHT REMEDIES NIGHTTIME SEVERE COLD AND FLU softgel	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Strive Pharmaceuticals Inc.	9f050fb0-6100-4b14-b82f-1d5fcbf16540	2025-09-22	Warnings	Exact identifier application number: M012
RIGHT REMEDIES DAYTIME SEVERE COLD AND FLU softgel	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Strive Pharmaceuticals Inc.	c6392ace-c7d1-4450-8b71-4dccc60b4f02	2025-09-22	Warnings	Exact identifier application number: M012
Giltuss Cough and Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Dextrum Laboratories Inc.	3f12ee8f-d1c6-d73a-e063-6394a90a9199	2025-09-18	Warnings	Exact identifier application number: M012
Giltuss D	GILTUSS D	Dextrum Laboratories Inc.	3f17eefb-b625-b0f2-e063-6294a90afd4d	2025-09-18	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1369842	acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution	PSN	8d41defe-8120-4cbb-b42e-c805cc5a794b	6
1369842	acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution	SCD	8d41defe-8120-4cbb-b42e-c805cc5a794b	6
1369842	acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution	SY	8d41defe-8120-4cbb-b42e-c805cc5a794b	6
1369842	acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution	SY	8d41defe-8120-4cbb-b42e-c805cc5a794b	6
1369842	APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / Guaifenesin 13.3 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution	SY	8d41defe-8120-4cbb-b42e-c805cc5a794b	6
2637731	{1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) / 1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) } Pack	GPCK	eb58871d-f351-47a1-aeab-254ec6693ddd	4
2637731	1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution) Pack	PSN	eb58871d-f351-47a1-aeab-254ec6693ddd	4
1369842	acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution	PSN	eb58871d-f351-47a1-aeab-254ec6693ddd	4
1431245	acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution	PSN	eb58871d-f351-47a1-aeab-254ec6693ddd	4
1431245	acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution	SCD	eb58871d-f351-47a1-aeab-254ec6693ddd	4
1369842	acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution	SCD	eb58871d-f351-47a1-aeab-254ec6693ddd	4
2637731	1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG per 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 mL Oral Solution) Pack	SY	eb58871d-f351-47a1-aeab-254ec6693ddd	4
1431245	acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution	SY	eb58871d-f351-47a1-aeab-254ec6693ddd	4
1369842	acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution	SY	eb58871d-f351-47a1-aeab-254ec6693ddd	4
1431245	acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution	SY	eb58871d-f351-47a1-aeab-254ec6693ddd	4
1369842	acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution	SY	eb58871d-f351-47a1-aeab-254ec6693ddd	4
1431245	APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution	SY	eb58871d-f351-47a1-aeab-254ec6693ddd	4
1369842	APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / Guaifenesin 13.3 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution	SY	eb58871d-f351-47a1-aeab-254ec6693ddd	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11822-0710-1	11822071001	355 mL in 1 BOTTLE (11822-0710-1)	355 ml	2014-06-18	2026-12-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rite Aid Corporation Daytime Nighttime Severe Cold & Flu Relief Drug Facts	Rite Aid Corporation	2026-09-10	HUMAN OTC DRUG LABEL	5
Rite Aid Corporation Daytime Severe Cold & Flu Relief Drug Facts	Rite Aid Corporation	2026-07-24	HUMAN OTC DRUG LABEL	7