Daytime Cold and Flu

Product NDC: 63868-020
11-digit product format: 638680020
Labeler code: 63868
Product ID: 63868-020_da167ca4-2477-45d1-974d-f784025ca7d3
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Dosage form: LIQUID
Route: ORAL
Labeler: QUALITY CHOICE (Chain Drug Marketing Association)
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-06-30
Marketing end: 2027-01-30
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 325; 10; 5 mg/15mL; mg/15mL; mg/15mL
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], 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 Cold and Flu
Brand name suffix: Non Drowsy

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup
9D2RTI9KYH	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
1113705	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
df866cf6-0526-4e61-ac9b-245b57dd5df6	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63868-020-08	Daytime Cold and FluNon Drowsy	237 mL in 1 BOTTLE, PLASTIC	LIQUID	237		7
63868-020-12	Daytime Cold and FluNon Drowsy	355 mL in 1 BOTTLE, PLASTIC	LIQUID	355		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63868-020-08	ML - Milliliter	63868-020	e7745249-c4b3-4c2f-83bd-3ec0f2ac7560	1	2018-03-08
63868-020-12	ML - Milliliter	63868-020	13afa728-907f-40f1-8d08-ee8a4a0af195	1	2018-03-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	DAYTIME COLD AND FLU NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	DAYTIME COLD AND FLU NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	DAYTIME COLD AND FLU NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	DAYTIME COLD AND FLU NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	DAYTIME COLD AND FLU NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	DAYTIME COLD AND FLU NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	DAYTIME COLD AND FLU NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DAYTIME COLD AND FLU NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	DAYTIME COLD AND FLU NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DAYTIME COLD AND FLU NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	DAYTIME COLD AND FLU NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	DAYTIME COLD AND FLU NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	DAYTIME COLD AND FLU NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	DAYTIME COLD AND FLU NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	DAYTIME COLD AND FLU NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	DAYTIME COLD AND FLU NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	DAYTIME COLD AND FLU NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	DAYTIME COLD AND FLU NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63868-020	DAYTIME COLD AND FLU NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	6	Current NDC, Legacy NDC, 2 package rows	20240423_df866cf6-0526-4e61-ac9b-245b57dd5df6.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 97 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Giltuss DM	DEXTROMETHORPHAN HBR	Gil Pharmaceutical Corp	1a4fe686-3085-4543-bd6c-f20580b1df50	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss D Allergy and Congestion	CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Gil Pharmaceutical Corp	8591003c-c2ec-df65-e053-2a91aa0a42fb	2025-10-09	Warnings	Exact identifier application number: M012
Gilphex	GUAIFENESIN, PHENYLEPHRINE HCL	Gil Pharmaceutical Corp.	e7c8fb97-02cf-4df6-b477-9ff69d6b675d	2025-10-09	Warnings	Exact identifier application number: M012
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	Rite Aid Corporation	d9f26677-ddef-4098-b564-9aa5734e088b	2025-10-09	Warnings	Exact identifier application number: M012
Kalaya Breathe Easy Vaporizing Rub	VAPORIZING RUB	Avaria Health & Beauty Corp	7adf96b1-03af-a87b-e053-2a91aa0a4585	2025-10-08	Warnings	Exact identifier application number: M012
Equate Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Walmart Inc	01e1f418-c232-e89e-e063-6294a90abd35	2025-10-08	Warnings	Exact identifier application number: M012
Equate	OXYMETAZOLINE HCL	Walmart Inc	020942b1-59d4-a19d-e063-6394a90a5d87	2025-10-08	Warnings	Exact identifier application number: M012
Cough Drops Dollar General Assorted Flavors 80ct	MENTHOL	Dollar General	425d2e63-f5bc-45fb-b330-967ae64cfddb	2025-10-08	Warnings	Exact identifier application number: M012
Cough Drops Dollar General Cherry 200ct	MENTHOL	Dollar General Corporation	a17aece2-abd8-452a-9da8-2e303845900b	2025-10-08	Warnings	Exact identifier application number: M012
Cough Drops Dollar General Cherry 30ct	MENTHOL	Dollar General Corporation	b96268da-d6f2-41e4-ba04-ce419376f626	2025-10-08	Warnings	Exact identifier application number: M012
Cough Drops Dollar General Cherry 30ct	MENTHOL	Dollar General Corporation	51ccf39a-ae9b-4e6a-856c-002c296f5d07	2025-10-08	Warnings	Exact identifier application number: M012
Cough Drops Dollar General Honey Lemon 200ct	MENTHOL	Dollar General Corporation	8f8a9474-f388-4ede-85f2-86222b15ee58	2025-10-08	Warnings	Exact identifier application number: M012
Cough Drops Dollar General Honey Lemon 200ct	MENTHOL	Dollar General Corporation	f85f1a15-db7f-4bb5-9313-24702660054e	2025-10-08	Warnings	Exact identifier application number: M012
Cough Drops Dollar General Honey Lemon 30ct	MENTHOL	Dollar General Corporation	61a23ce6-5157-4076-afa7-6a79c62fe9e0	2025-10-08	Warnings	Exact identifier application number: M012
Cough Drops Dollar General Honey Lemon 30ct	MENTHOL	Dollar General Corporation	d5fb7d9e-b0f6-4424-bf67-9e72b50366b1	2025-10-08	Warnings	Exact identifier application number: M012
Cough Drops Dollar General Menthol 160ct	MENTHOL	Dollar General Corporation	9f9916f5-83ea-4f36-b8c2-c6fe1f77884b	2025-10-08	Warnings	Exact identifier application number: M012
Cough Drops Dollar General Menthol 80ct	MENTHOL	Dollar General Corporation	a23ec89a-de7e-4013-b85b-1593e18dc28e	2025-10-08	Warnings	Exact identifier application number: M012
Cough Drops Dollar General Menthol 160ct	MENTHOL	Dollar General Corporation	1833d3bf-6f01-4122-9f4d-4d8b2423fcbb	2025-10-08	Warnings	Exact identifier application number: M012
Cough Drops Dollar General Menthol 30ct	MENTHOL	Dollar General Corporation	fbe92e39-6470-4634-b976-e316baa2c995	2025-10-08	Warnings	Exact identifier application number: M012
Equate	VAPORIZING STEAM LIQUID	Walmart Inc.	ffede19a-06e2-61c7-e053-6394a90ac77b	2025-10-08	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
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1113705	acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution	PSN	df866cf6-0526-4e61-ac9b-245b57dd5df6	7
1113705	acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution	SCD	df866cf6-0526-4e61-ac9b-245b57dd5df6	7
1113705	acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution	SY	df866cf6-0526-4e61-ac9b-245b57dd5df6	7
1113705	acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution	SY	df866cf6-0526-4e61-ac9b-245b57dd5df6	7
1113705	APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution	SY	df866cf6-0526-4e61-ac9b-245b57dd5df6	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63868-020-08	63868002008	237 mL in 1 BOTTLE, PLASTIC (63868-020-08)	237 ml	2015-06-30	2027-01-30	No	No	Current
63868-020-12	63868002012	355 mL in 1 BOTTLE, PLASTIC (63868-020-12)	355 ml	2015-06-30	2027-01-30	No	No	Current