Ampigrin Ultra Forte Night

Product NDC: 69729-003
11-digit product format: 697290003
Labeler code: 69729
Product ID: 69729-003_3a229cae-7c0d-a174-e063-6394a90a2efc
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	69729-003		I	Inactivated by FDA		excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69729-003	69729-003-10	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: Ampigrin Ultra Forte Night
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
e11e71c3-fe7c-77c7-e053-2995a90a34b2	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
69729-003-10	2024-04-05	C162847	48780-1	1030e365-4177-111a-e063-dadaa90a10e2	Ampigrin Ultra Forte - Night
69729-003-10	2024-01-30	C162847	48780-1	1030e365-4177-111a-e063-dadaa90a10e2	Ampigrin Ultra Forte - Night

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69729-003-10	Ampigrin Ultra Forte Night	10 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	10		3
69729-003-10	Ampigrin Ultra Forte Night	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
69729-003	AMPIGRIN ULTRA FORTE NIGHT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [OPMX LLC]	2	Current NDC, Legacy NDC, 2 package rows	20240407_e11e71c3-fe7c-77c7-e053-2995a90a34b2.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 176 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Stona Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Sato Pharmaceutical Co., Ltd.	0b638db4-5ed3-4665-abcd-f95e677adbd8	2023-11-12	Warnings	Exact identifier application number: M012
Tylenol Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Jones Healthcare Group - Packaging Services, Inc	6c90b415-4c5f-49e5-beb6-4cf225797b21	2023-11-06	Warnings	Exact identifier application number: M012
Tylenol Cold Plus Flu Severe Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Jones Healthcare Group - Packaging Services, Inc	8b8582c0-8aef-482f-9738-2f1d4e325d64	2023-11-06	Warnings	Exact identifier application number: M012
Cold and Flu Severe Daytime/Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Topco Associates LLC	27ade5f8-2003-4dc6-9244-42676791e1f8	2023-11-06	Warnings	Exact identifier application number: M012
Benadryl Allergy Ultratab	DIPHENHYDRAMINE HYDROCHLORIDE	Jones Healthcare Group - Packaging Services, Inc	ec2070df-8a8a-4cd1-8830-62655433fb3b	2023-11-05	Warnings	Exact identifier application number: M012
Daytime Nighttime Ultra Concentrated Cold and Flu	DAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE	TARGET CORPORATION	093eed84-79b1-7914-e063-6394a90a37af	2023-11-03	Warnings	Exact identifier application number: M012
Cough Drops	MENTHOL	Topco Associates LLC	eff68377-2273-6c6c-e053-2995a90a36b2	2023-11-03	Warnings	Exact identifier application number: M012
Sugar Free Cough Drops	MENTHOL	Topco Associates LLC	096bbcaa-fce1-0fc2-e063-6294a90ad597	2023-11-03	Warnings	Exact identifier application number: M012
TopCare Nite Time SEVERE Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	adc8edf5-ebbe-4d94-9018-aa0dbe118112	2023-11-03	Warnings	Exact identifier application number: M012
MUCOSA	GUAIFENESIN	TIME CAP LABORATORIES,INC	d34ef2e8-adc2-48e5-a572-e354937daec6	2023-11-02	Warnings	Exact identifier application number: M012
Daytime Severe and Nighttime Severe cold and flu	DAYTIME SEVERE - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN AND NIGHTTIME SEVERE-ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	TARGET CORPORATION	09286d15-b63f-a9de-e063-6294a90ab948	2023-11-02	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	AMERIFOODS TRADING COMPANY	f6cece6c-23e4-7811-e053-6394a90a106a	2023-11-02	Warnings	Exact identifier application number: M012
Sinus Pressure plus Pain PE	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC.	eb64750f-19ac-655f-e053-2995a90a33b5	2023-11-02	Warnings	Exact identifier application number: M012
Multi-Symptom Mapap Cold Formula	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Proficient Rx LP	9bf81b26-38b4-486c-ae89-222119ce1a4f	2023-11-01	Warnings	Exact identifier application number: M012
Guaifenesin Syrup and Dextromethorphan	GUAIFENESIN SYRUP AND DEXTROMETHORPHAN	Natco Pharma USA LLC	ad9026f4-f0b6-4d02-aa44-f0460eeefc0e	2023-11-01	Warnings	Exact identifier application number: M012
Diphenhydramine HCl Oral Solution	DIPHENHYDRAMINE HYDROCHLORIDE	Natco Pharma USA LLC	54b64354-ac10-42ff-a53d-96cef933a91a	2023-11-01	Warnings	Exact identifier application number: M012
children allergy relief dye free cherry	DIPHENHYDRAMINE HCL	A-S Medication Solutions	5c6c1809-4c6f-4e8f-a5ae-9796e821d400	2023-11-01	Warnings	Exact identifier application number: M012
Daytime and Nighttime Cherry Cold and Flu	DAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE	TARGET CORPORATION	0903b222-1a44-64aa-e063-6294a90abba0	2023-10-31	Warnings	Exact identifier application number: M012
Ephrine Nose Drops	PHENYLEPHRINE HYDROCHLORIDE	Walgreens	b620eb9f-2caf-0942-e053-2a95a90ae48e	2023-10-31	Warnings	Exact identifier application number: M012
pseudoephedrine hydrochloride	PSEUDOEPHEDRINE HCL	A-S Medication Solutions	204849d1-ac4b-4dbe-8769-fcb30291f880	2023-10-31	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	e11e71c3-fe7c-77c7-e053-2995a90a34b2	3
1094549	acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule	SCD	e11e71c3-fe7c-77c7-e053-2995a90a34b2	3
1094549	APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule	SY	e11e71c3-fe7c-77c7-e053-2995a90a34b2	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69729-003-10	69729000310	10 BLISTER PACK in 1 CARTON (69729-003-10) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	10 blister pack	2022-06-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ampigrin Ultra Forte - Night	OPMX LLC \| OCEAN HEALTHCARE PVT. LTD.	2025-07-17	HUMAN OTC DRUG LABEL	3