DOLOGEN

Product NDC: 52083-483
11-digit product format: 520830483
Labeler code: 52083
Product ID: 52083-483_19820911-7642-4293-b03e-5359d59661d6
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Dexbrompheniramine maleate
Dosage form: TABLET
Route: ORAL
Labeler: Kramer Novis
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-12-15
Substance: ACETAMINOPHEN; DEXBROMPHENIRAMINE MALEATE
Active strength: 500; 2 mg/1; mg/1
NDC exclude flag: No
Listing certified through: 2027-12-31
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: DOLOGEN
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	500 mg/1
DEXBROMPHENIRAMINE MALEATE	2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup
BPA9UT29BS	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2729424	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
656ea9ba-c9cf-44c6-af40-b8ba292ce38a	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52083-483-90	DOLOGEN	90 in 1 BOTTLE, PLASTIC	TABLET	90		1

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 124 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Right Remedies Adult Long Lasting Cough Relief Softgel	DEXTROMETHORPHAN HYDROBROMIDE	Strive Pharmaceuticals Inc.	e3ea468e-4e12-4dae-b222-8e32456b77b8	2025-01-02	Warnings	Exact identifier application number: M012
AVON HeXashield Congestion Relief Original	OXYMETAZOLINE HYDROCHLORIDE	Tai Guk Pharm. Co., Ltd.	8f2c152c-c564-0cba-e053-2a95a90ab3c7	2025-01-01	Warnings	Exact identifier application number: M012
Multi-Symptom Nighttime Cold and Flu Relief	ACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBR	Advanced Rx LLC	a75553bd-f3f0-47bd-b3c3-aeeb0d1a81b4	2025-01-01	Warnings	Exact identifier application number: M012
Cough Relief	DEXTROMETHORPHAN HYDROBROMIDE	Advanced Rx LLC	297e10e3-e740-4434-91a2-2e5c54985d33	2025-01-01	Warnings	Exact identifier application number: M012
MUCUS RELIEF DM	GUAIFENESIN, DEXTROMETHORPHAN HBR	Advanced Rx LLC	64620186-a45b-4c35-a3b9-a347348f93f7	2025-01-01	Warnings	Exact identifier application number: M012
DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Best Choice	57a44bbf-a304-47b9-8adc-4442c7787853	2025-01-01	Warnings	Exact identifier application number: M012
Long Acting Cough Softgels	DEXTROMETHORPHAN HYDROBROMIDE	CVS PHARMACY, INC	322daee6-c61d-43d3-a54d-a354fd3df242	2025-01-01	Warnings	Exact identifier application number: M012
Adult Tussin DM Lil Drug Store Products	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Lil' Drug Store Products, Inc	1915cf2a-ebaa-4c47-8991-5b741fa01be2	2024-12-31	Warnings	Exact identifier application number: M012
Congestion Relief Lil Drug Store Products	OXYMETAZOLINE HYDROCHLORIDE	Lil' Drug Store Products, Inc	8fca348c-ecb6-4a91-89dd-8bd4c05ac745	2024-12-31	Warnings	Exact identifier application number: M012
DAYTIME COLD AND FLU MULTI SYMPTOM	DAYTIME COLD AND FLU MULTI SYMPTOM	TARGET CORP	9dea350d-2f09-b944-e053-2995a90a2b63	2024-12-30	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Walgreens	2b7aa3f5-3bc9-471f-8ff7-3c52719f0acb	2024-12-30	Warnings	Exact identifier application number: M012
Pediacare Childrens Cough and Cold Grape	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH	fabafdc1-9dd8-4258-af49-bab1e29ad109	2024-12-30	Warnings	Exact identifier application number: M012
Pediacare Childrens Cough and Congestion Grape	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH	9576723b-748c-45e7-bc0d-cc109b9f6735	2024-12-30	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Lil' Drug Store Products, Inc.	ef6836fa-d104-d7b3-e053-2a95a90af2b8	2024-12-30	Warnings	Exact identifier application number: M012
Circle K Congestion Relief	OXYMETAZOLINE HYDROCHLORIDE	Lil' Drug Store Products, Inc	7e02fe57-f42f-4d3c-9002-4c4c0b1fafd6	2024-12-30	Warnings	Exact identifier application number: M012
SDA Laboratories Tussin	GUAIFENESIN	SDA Laboratories, Inc.	2a444cc8-96be-9432-e063-6394a90a1b63	2024-12-27	Warnings	Exact identifier application number: M012
SDA Laboratories Tussin DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	SDA Laboratories, Inc.	2a445f31-818d-11b1-e063-6294a90a8cb1	2024-12-27	Warnings	Exact identifier application number: M012
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Richmond Pharmaceuticals Inc.	f184b2aa-91a4-44f9-b688-d4e318181984	2024-12-26	Warnings	Exact identifier application number: M012
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Richmond Pharmaceuticals, Inc.	2792032a-ff0f-4d5f-a8e3-b8b8c54f4e99	2024-12-26	Warnings	Exact identifier application number: M012
OXYMETAZOLINE HYDROCHLORIDE	OXYMETAZOLINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC.	c7b1f980-9b0d-4f63-a70d-fd366658f863	2024-12-26	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
BPA9UT29BS	DEXBROMPHENIRAMINE MALEATE	2391-03-9	DEXBROMPHENIRAMINE MALEATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2729424	acetaminophen 500 MG / dexbrompheniramine maleate 2 MG Oral Tablet	PSN	656ea9ba-c9cf-44c6-af40-b8ba292ce38a	1
2729424	acetaminophen 500 MG / dexbrompheniramine maleate 2 MG Oral Tablet	SCD	656ea9ba-c9cf-44c6-af40-b8ba292ce38a	1
2729424	APAP 500 MG / dexbrompheniramine maleate 2 MG Oral Tablet	SY	656ea9ba-c9cf-44c6-af40-b8ba292ce38a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
52083-483-90	52083048390	90 TABLET in 1 BOTTLE, PLASTIC (52083-483-90)	90 tablet	2025-12-15	No	No	Current