AXIM DayTime - Night Time 72 Softgels

Product NDC: 82706-004
11-digit product format: 827060004
Labeler code: 82706
Product ID: 82706-004_4251d4a4-6904-fa3d-e063-6294a90ae93d
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride
Dosage form: KIT
Labeler: VIVUNT PHARMA LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-05-09
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 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	82706-004-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	82706-004-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	82706-004-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	82706-004-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	82706-004-01	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	82706-004-01	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	82706-004-01	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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: AXIM DayTime - Night Time 72 Softgels
Listing expiration: 2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1086997	Internal RxNorm lookup
1094549	Internal RxNorm lookup
2634564	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
de9eb2d5-ba51-4637-e053-2995a90a0451	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#

Effective, Related label table
Effective	Related label
2025-08-20	AXIM DayTime & Night Time
2025-08-20	AXIM DayTime & Night Time
2025-01-30	AXIM DayTime & Night Time
2025-01-30	AXIM DayTime & Night Time

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82706-004-01	AXIM DayTime - Night Time 72 Softgels	1 in 1 PACKAGE	KIT	1		10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82706-004	AXIM DAYTIME - NIGHT TIME 48 SOFTGELS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE) KIT AXIM DAYTIME - NIGHT TIME 72 SOFTGELS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE) KIT [VIVUNT PHARMA LLC]	8	Current NDC, Legacy NDC, 1 package rows	20230209_de9eb2d5-ba51-4637-e053-2995a90a0451.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 169 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
THERAFLU POWERPODS NIGHTTIME SEVERE COLD	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Haleon US Holdings LLC	39f9feef-4bf2-4f10-9fff-22bbb1d8a471	2024-01-30	Warnings	Exact identifier application number: M012
Theraflu Daytime Severe Cold and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE	Haleon US Holdings LLC	c0689223-5c90-4dbc-bbfa-f94e267504c3	2024-01-28	Warnings	Exact identifier application number: M012
THERAFLU MULTI-SYMPTOM SEVERE COLD	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Haleon US Holdings LLC	a4c56ca0-7785-404b-996d-137cc135f270	2024-01-28	Warnings	Exact identifier application number: M012
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2634564	{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule) } Pack	GPCK	de9eb2d5-ba51-4637-e053-2995a90a0451	10
2634564	1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) Pack	PSN	de9eb2d5-ba51-4637-e053-2995a90a0451	10
1086997	acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule	PSN	de9eb2d5-ba51-4637-e053-2995a90a0451	10
1094549	acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule	PSN	de9eb2d5-ba51-4637-e053-2995a90a0451	10
1086997	acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule	SCD	de9eb2d5-ba51-4637-e053-2995a90a0451	10
1094549	acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule	SCD	de9eb2d5-ba51-4637-e053-2995a90a0451	10
2634564	1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) Pack	SY	de9eb2d5-ba51-4637-e053-2995a90a0451	10
1086997	APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule	SY	de9eb2d5-ba51-4637-e053-2995a90a0451	10
1094549	APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule	SY	de9eb2d5-ba51-4637-e053-2995a90a0451	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
82706-004-01	82706000401	1 KIT in 1 PACKAGE (82706-004-01) * 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	1 kit	2022-05-09	0000-00-00	No	No	Current