Viro Flu PM Relief

Product NDC: 69729-057
11-digit product format: 697290057
Labeler code: 69729
Product ID: 69729-057_3a22dcb9-df62-4163-e063-6294a90a5039
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: OPMX LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-06-10
Substance: DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; ACETAMINOPHEN
Active strength: 15; 6.25; 325 mg/1; mg/1; mg/1
Pharmacologic classes: Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product	69729-057		I	Inactivated by FDA		excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69729-057	69729-057-10	I	Inactivated by FDA		excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`

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: Viro Flu PM Relief
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	15 mg/1
DOXYLAMINE SUCCINATE	6.25 mg/1
ACETAMINOPHEN	325 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9D2RTI9KYH	Internal UNII lookup
V9BI9B5YI2	Internal UNII lookup
362O9ITL9D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1094549	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
e1553da8-3a89-e258-e053-2a95a90a4725	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
f4368033-af8c-41bf-a84b-ff77392b8522	Product name	1	20161229

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69729-057-10	2024-04-05	C162847	48780-1	1030e365-0fb4-111a-e063-dadaa90a10e2	Viro-Flu PM Relief
69729-057-10	2024-01-30	C162847	48780-1	1030e365-0fb4-111a-e063-dadaa90a10e2	Viro-Flu PM Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69729-057-10	Viro Flu PM Relief	10 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	10		3
69729-057-10	Viro Flu PM Relief	10 in 1 CARTON	CAPSULE, LIQUID FILLED	10		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69729-057	VIRO FLU PM RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [OPMX LLC]	2	Current NDC, Legacy NDC, 2 package rows	20240407_e1553da8-3a89-e258-e053-2a95a90a4725.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 170 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
THERAFLU NIGHTTIME SEVERE COLD AND COUGH	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Haleon US Holdings LLC	5f7f6f70-0f36-4541-89f2-d953259cdb1e	2024-01-28	Warnings	Exact identifier application number: M012
RESFRIOL D	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	OPMX LLC	0e9c96b9-41ac-0faf-e063-6294a90a8ab5	2024-01-26	Warnings	Exact identifier application number: M012
Allergy Relief	ALLERGY RELIEF	Good Sense	bb709377-7bb3-4931-a2b6-2443aee07c12	2024-01-26	Warnings	Exact identifier application number: M012
Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Haleon US Holdings LLC	721bfee2-0d3d-4d8b-beee-1ea83064d1c8	2024-01-23	Warnings	Exact identifier application number: M012
Sugar Free Cough Drops Honey Lemon	MENTHOL	Cardinal Health 110, Inc.	fe90dc33-2815-8296-e053-6294a90ac1df	2024-01-19	Warnings	Exact identifier application number: M012
Sugar Free Cough Drops	MENTHOL	Cardinal Health 110, Inc.	fe91543e-a798-6399-e053-6394a90af5e5	2024-01-19	Warnings	Exact identifier application number: M012
Sugar Free Cough Drops Black Cherry	MENTHOL	Cardinal Health 110, Inc.	fe90cf63-d286-fa5e-e053-6394a90a7759	2024-01-19	Warnings	Exact identifier application number: M012
Cough Drops Menthol Honey Lemon	COUGH DROPS MENTHOL	Cardinal Health 110, Inc.	fe5b3f6d-2a2d-f322-e053-6394a90aba04	2024-01-19	Warnings	Exact identifier application number: M012
Cough Drops Menthol	MENTHOL COUGH DROPS	Cardinal Health 110, Inc.	fe5b557e-a689-a32c-e053-6294a90aadbd	2024-01-19	Warnings	Exact identifier application number: M012
Cough Drops Cherry	CHERRY FLAVOR COUGH DROPS	Cardinal Health 110, Inc.	fe5b5e57-1368-c62b-e053-6294a90ae82c	2024-01-19	Warnings	Exact identifier application number: M012
Leader Zinc Oxide	ZINC OXIDE	Cardinal Health 110,Inc.	4d675dfd-6ea9-4aa7-a4ff-bb84f87ff7d1	2024-01-18	Warnings	Exact identifier application number: M012
Cough and Congestion DM Sugar Free	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Best Choice (Valu Merchandisers Company)	4656e60e-4733-45c1-bf55-d156e45085c6	2024-01-17	Warnings	Exact identifier application number: M012
Nasal Decongestant	PSEUDOEPHEDRINE HCL	Rugby Laboratories	775f97c0-6f82-49a8-82ac-f1a73920c3ec	2024-01-11	Warnings	Exact identifier application number: M012
SinuFrin NeilMed	OXYMETAZOLINE HYDROCHLORIDE	NeilMed Pharmaceuticals Inc	f9ec6ac3-1e00-4e97-97c8-b2cd66a752ae	2024-01-11	Warnings	Exact identifier application number: M012
SinuFrin Plus NeilMed	OXYMETAZOLINE HYDROCHLORIDE	NeilMed Pharmaceuticals, Inc.	99afe6a6-1350-49c6-9347-b7e531e35925	2024-01-11	Warnings	Exact identifier application number: M012
Childrens Tukol Multi-Symptom Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Genomma Lab USA, Inc.	85fe6f0f-41c8-44d3-a34a-355938da5f72	2024-01-11	Warnings	Exact identifier application number: M012
Allergy Relief Diphenhydramine HCl	DIPHENHYDRAMINE HYDROCHLORIDE	Cardinal Health 110, LLC. DBA Leader	ad437177-08eb-4811-883f-ac543d5bc58c	2024-01-11	Warnings	Exact identifier application number: M012
Allergy Antihistamine	DIPHENHYDRAMINE HYDROCHLORIDE	KROGER COMPANY	af5053d8-ba02-4cdf-877f-8c1e368dafe0	2024-01-10	Warnings	Exact identifier application number: M012
HISTEX	TRIPROLIDINE HYDROCHLORIDE	Allegis Pharmaceuticals, LLC	cc466d33-cf3e-4f1c-a794-6d3d79903adf	2024-01-08	Warnings	Exact identifier application number: M012
HISTEX-DM	DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Allegis Pharmaceuticals, LLC	836d062c-29f0-4fd7-b65c-771a3bbd52c4	2024-01-08	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
V9BI9B5YI2	DOXYLAMINE SUCCINATE	562-10-7	DOXYLAMINE SUCCINATE
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1094549	acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule	PSN	e1553da8-3a89-e258-e053-2a95a90a4725	3
1094549	acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule	SCD	e1553da8-3a89-e258-e053-2a95a90a4725	3
1094549	APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule	SY	e1553da8-3a89-e258-e053-2a95a90a4725	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69729-057-10	69729005710	10 BLISTER PACK in 1 CARTON (69729-057-10) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	10 blister pack	2022-06-10	0000-00-00	No	No	Current