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 95 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Signature Care Original	OXYMETAZOLINE HYDROCHLORIDE	SAFEWAY, INC.	f7ad687b-dcaf-928c-e053-6294a90a6abe	2025-10-16	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Care One (Retail Business Services, LLC.)	90ccb29c-9967-46cb-a409-e440344e1a1a	2025-10-15	Warnings	Exact identifier application number: M012
Robitussin Childrens Honey Day Night DM Value Pack	DEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATE	Haleon US Holdings LLC	f9999875-3433-4052-a628-39539d373216	2025-10-15	Warnings	Exact identifier application number: M012
Robitussin Day and Night Cough Relief Value Pack	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, CHLORPHENIRAMINE MALEATE	Haleon US Holdings LLC	4029eccd-5443-4ae2-9232-2a1d922798f8	2025-10-15	Warnings	Exact identifier application number: M012
EndaCof DM	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE	Larken Laboratories, Inc.	c68ea55a-8b9a-4a70-8b5c-1a2736651813	2025-10-15	Warnings	Exact identifier application number: M012
DURATUSS DM	DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	Poly Pharmaceuticals, Inc.	413a3951-d704-f14b-e063-6394a90a06dc	2025-10-15	Warnings	Exact identifier application number: M012
LoHist DM	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE	Larken Laboratories, Inc.	29730dab-fa09-4351-9b36-0359ba4f7744	2025-10-15	Warnings	Exact identifier application number: M012
M-END DMX	DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE	R. A. McNeil Company	ee1fae2e-3a21-4487-9989-c7620a4a7056	2025-10-15	Warnings	Exact identifier application number: M012
Chlo Tuss	CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE	R.A. McNeil Company	43610aaa-8b94-40d5-ae09-3d75bd2317c8	2025-10-15	Warnings	Exact identifier application number: M012
Chlo Hist	CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE	R. A. McNeil Company	d046f4ba-5753-4ed5-a924-0b66fd116781	2025-10-15	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Care One (Retail Business Services, LLC.)	6ca7372b-50c4-4b15-b133-fefa35525ade	2025-10-15	Warnings	Exact identifier application number: M012
Extra Strength Sinus Relief Nasal Decongestant	PHENYLEPHRINE HYDROCHLORIDE	CARDINAL HEALTH	0d8a009c-30b5-4f12-90bd-f8aa1110243f	2025-10-14	Warnings	Exact identifier application number: M012
Tussin DM Cough plus Chest Congestion	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Cardinal Health 110, Inc. DBA LEADER	9d11f443-c93d-44e8-b5a3-2677b7b11212	2025-10-14	Warnings	Exact identifier application number: M012
Rompe Pecho SF	GUAIFENESIN	Efficient Laboratories, Inc.	31ff48fc-9603-413c-ab7c-2598b3e08f9c	2025-10-14	Warnings	Exact identifier application number: M012
Rompe Pecho DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Efficient Laboratories Inc	d108c712-bc36-41d7-9ccd-720496b5599e	2025-10-14	Warnings	Exact identifier application number: M012
Rompe Pechito DM for Kids	DEXTROMETHORPHAN HBR, GUAIFENESIN	Efficient Laboratories Inc	004d12e1-6e3d-84c8-e063-6394a90aa653	2025-10-14	Warnings	Exact identifier application number: M012
VANACOF CP Allergy / Cough	CHLOPHEDIANOL HCL, PYRILAMINE MALEATE	GM Pharmaceuticals, INC	0bdea30a-39da-6611-e063-6394a90aa4cf	2025-10-14	Warnings	Exact identifier application number: M012
VANACOF	CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE	GM Pharmaceuticals, INC	cf3886ab-62b3-497a-a587-18cbfbaf3634	2025-10-14	Warnings	Exact identifier application number: M012
Sugar Free Cherry Fishermans Friend Menthol Cough Suppressant	MENTHOL	Lofthouse of Fleetwood, Ltd.	42d4bafb-b630-487e-b63d-13ad37a59454	2025-10-14	Warnings	Exact identifier application number: M012
SUPRESS A	DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Dextrum Laboratories, Inc	410c19f7-213d-cd99-e063-6294a90af5a3	2025-10-13	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