Cold Multi-Symptom

Product NDC: 69168-324
11-digit product format: 691680324
Labeler code: 69168
Product ID: 69168-324_b31c44ba-30a7-4731-8169-2a3f2a5de4d5
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Allegiant Health
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-08-15
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 325; 10; 5 mg/1; mg/1; mg/1
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
Listing certified through: 2026-12-31
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: Cold Multi-Symptom
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE	10 mg/1
PHENYLEPHRINE HYDROCHLORIDE	5 mg/1

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
1094538	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
9a4c0c43-a71a-4e22-a3d5-9eb9622689a2	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
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
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
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
69168-324-86	Cold Multi-Symptom	1 in 1 CARTON	TABLET, COATED	1		5
69168-324-86	Cold Multi-Symptom	12 in 1 BLISTER PACK	TABLET, COATED	12		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69168-324	COLD MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET, COATED [ALLEGIANT HEALTH]	5	Current NDC, Legacy NDC, 2 package rows	20231115_9a4c0c43-a71a-4e22-a3d5-9eb9622689a2.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 52 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Equaline Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	United Natural Foods, Inc. dba UNFI	739237a5-cc62-8ad6-e053-2991aa0a91f8	2024-12-17	Warnings	Exact identifier application number: M013
NOTTS - Muscle Aches and Pain	ACETAMINOPHEN	VIVUNT PHARMA LLC	e6741300-4573-2580-e053-2a95a90a599c	2024-12-17	Warnings	Exact identifier application number: M013
Extra Strength Pain Reliever, Caseys 4good	ACETAMINOPHEN 500MG, FILM-COATED CAPLET	Lil' Drug Store Products, Inc.	e5fc5340-c224-e02b-e053-2a95a90a5297	2024-12-16	Warnings	Exact identifier application number: M013
Pain Reliever, Caseys 4good	ACETAMINOPHEN 500 MG, TABLET	Lil' Drug Store Products, Inc.	039d2cf1-57f6-4d9d-e063-6394a90a5492	2024-12-16	Warnings	Exact identifier application number: M013
Extra Strength Headache, Caseys 4good	ACETAMINOPHEN, ASPIRIN, CAFFEINE TABLET	Lil' Drug Store Products, Inc.	0425c6a8-a3ea-24ad-e063-6294a90ae15a	2024-12-16	Warnings	Exact identifier application number: M013
Lil Drug Store Childrens Pain and Fever	ACETAMINOPHEN	Lil' Drug Store Products, Inc.	5fcd41ad-449f-4090-be19-eae4171de891	2024-12-16	Warnings	Exact identifier application number: M013
Acetaminophen 250mg Aspirin 250mg Caffeine 65mg	ACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MG	CVS Pharmacy	b9e75551-1e50-9896-e053-2a95a90aafd4	2024-12-14	Warnings	Exact identifier application number: M013
Acetaminophen 250mg Aspirin 250mg Caffeine 65mg	ACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MG	CVS Pharmacy	b9e5df0e-06d3-6f72-e053-2995a90a2d07	2024-12-14	Warnings	Exact identifier application number: M013
Alka-Seltzer Heartburn and Pain	ANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATE	Bayer HealthCare LLC.	2928e140-c868-5bf5-e063-6394a90ab024	2024-12-13	Warnings	Exact identifier application number: M013
foster and thrive pain reliever	ACETAMINOPHEN	Strategic Sourcing Services LLC	b8ee568c-80cf-4e35-865e-35516bdab0fd	2024-12-13	Warnings	Exact identifier application number: M013
Headache Relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Strive Pharmaceuticals Inc.	c0de0bd2-4868-46dc-a20f-3ca02caaa26b	2024-12-11	Warnings	Exact identifier application number: M013
Rite Aid Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Rite Aid	b4797380-9cef-d640-e053-2a95a90a0665	2024-12-11	Warnings	Exact identifier application number: M013
Top Value Effervescent Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICAROBONATE	Tower Laboratories Ltd	44babed8-cf38-1c12-e054-00144ff8d46c	2024-12-11	Warnings, Adverse reactions	Exact identifier application number: M013
Best Choice Effervescent Antacid Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Valu Merchandisers Company	b5e2300a-b77b-53cc-e053-2a95a90a7a6e	2024-12-11	Warnings	Exact identifier application number: M013
EXTRA STRENGTH Headache Relief geltabs	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Strive Pharmaceuticals Inc.	b432771a-4f7d-4d39-a038-d1561d8f6708	2024-12-11	Warnings	Exact identifier application number: M013
Pain Relief Childrens	ACETAMINOPHEN	QUALITY CHOICE (Chain Drug Marketing Association)	223ffb2b-3ee5-4118-955b-bc4fa4e8a2e6	2024-12-10	Warnings	Exact identifier application number: M013
acetaminophen	ACETAMINOPHEN	UNFI	e689c9e3-dd4d-c646-e053-2a95a90a4b6a	2024-12-09	Warnings	Exact identifier application number: M013
DrKids Childrens Pain and Fever	ACETAMINOPHEN 80MG/PIECE	CalmCo LLC	ff4b0528-39a0-80d5-e053-6394a90a8a83	2024-12-07	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	DISCOUNT DRUG MART	972f09a7-2aa1-4b1b-a6dc-2c4578a07803	2024-12-05	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	DISCOUNT DRUG MART	e6feff0a-3347-194d-e053-2a95a90acd20	2024-12-05	Warnings	Exact identifier application number: M013

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
1094538	acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Tablet	PSN	9a4c0c43-a71a-4e22-a3d5-9eb9622689a2	5
1094538	acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD	9a4c0c43-a71a-4e22-a3d5-9eb9622689a2	5
1094538	APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SY	9a4c0c43-a71a-4e22-a3d5-9eb9622689a2	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69168-324-86	69168032486	1 BLISTER PACK in 1 CARTON (69168-324-86) / 12 TABLET, COATED in 1 BLISTER PACK	1 blister pack	2015-08-15	0000-00-00	No	No	Current