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 96 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TexaClear Pain and Chest Congestion Relief	CHOLINE SALICYLATE,GUAIFENESIN	GM Pharmaceuticals, INC	672bc78a-2c71-4135-b64a-2b8c40ac688c	2025-10-13	Warnings	Exact identifier application number: M012
Vapor Stick	CAMPHOR/MENTHOL	Rejoice International Corp.	33d1fbf3-d33c-58b9-e063-6294a90ae098	2025-10-13	Warnings	Exact identifier application number: M012
Nitetime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Meijer Distribution Inc	47f03174-6e91-4529-bbfa-ce58aa7b7d79	2025-10-13	Warnings	Exact identifier application number: M012
Nasal Decongestant Maximum Strength	PSEUDOEPHEDRINE HCL	CHAIN DRUG MARKETING ASSOCIATION INC	db81e32b-0cad-400b-8479-a3b51de92b12	2025-10-10	Warnings	Exact identifier application number: M012
Giltuss Childrens Cough and Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Gil Pharmaceutical Corp	852b77ae-a5ac-3ead-e053-2a91aa0a54bd	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Cough and Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Gil Pharmaceutical Corp	8503c956-42a5-7684-e053-2991aa0adb27	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss HBP Cough and Chest Congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Gil Pharmaceutical Corp	852ceea2-d6a1-6de2-e053-2a91aa0ad50d	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Childrens Cough and Chest Congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Gil Pharmaceutical Corp	852d5f01-9289-5515-e053-2a91aa0acf32	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Diabetic Cough and Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Gil Pharmaceutical Corp	85183b38-ce2a-0e0e-e053-2991aa0a336f	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss MultiSymptom Cold and Flu	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Giltuss Pharmaceutical Corp	8518fd91-981e-de78-e053-2a91aa0afcb2	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Childrens MultiSymptom Cold and Flu	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Giltuss Pharmaceutical Corp	852c8cd6-271f-0fa8-e053-2991aa0ab179	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Allergy Plus Cough and Congestion	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Gil Pharmaceutical Corp	85065cf3-386d-22d5-e053-2a91aa0a72da	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Honey Cough and Chest Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	Gil Pharmaceutical Corp	a8b2c847-25e9-8714-e053-2995a90a73ce	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Childrens Allergy Plus Cough and Congestion	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Gil Pharmaceutical Corp	852c5a57-7ee4-3c5c-e053-2a91aa0a1433	2025-10-09	Warnings	Exact identifier application number: M012
Childrens Giltuss Honey DM Cough	DEXTROMETHORPHAN HBR	Gil Pharmaceutical Corp	a8c5027f-9701-fb07-e053-2a95a90a6029	2025-10-09	Warnings	Exact identifier application number: M012
Childrens Giltuss Honey Cough and Chest Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	Gil Pharmaceutical Corp	a8c052d8-fb9f-09f2-e053-2a95a90a37af	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss EX Expectorant	GUAIFENESIN	Gil Pharmaceutical Corp	a8c53c14-ba82-2c68-e053-2a95a90a9894	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Severe Sinus	OXYMETAZOLINE HCL	Gil Pharmaceutical Corp	ab7fae3b-1f7d-5d0f-e053-2a95a90a148e	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Honey DM Cough	DEXTROMETHORPHAN HBR	Gil Pharmaceutical Corp	a8c08532-1169-6603-e053-2a95a90a3484	2025-10-09	Warnings	Exact identifier application number: M012
Childrens Giltuss EX Expectorant	GUAIFENESIN	Gil Pharmaceutical Corp	a8c59e6d-c11c-2664-e053-2a95a90a8333	2025-10-09	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