NDC 68016-321-12 - Premier Value Hemorrhoidal

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 68016-321
Requested NDC: 68016-321-12
Package NDCs from labels: 68016-321-12, 68016-321-13
Manufacturer: Chain Drug Consortium | Unipack, Inc.
Effective date: 2015-03-25
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Premier Value Hemorrhoidal - Chain Drug Consortium \| Unipack, Inc.	Chain Drug Consortium \| Unipack, Inc.	2015-03-25	HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68016-321-13	2020-01-31	C162847	48780-1	9d75b9d0-b2f6-f424-e053-dadaa90a57ce	8638a48e-9f90-4cab-abc1-5407afe498df

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68016-321-12	Premier Value Hemorrhoidal	12 g in 1 BLISTER PACK	SUPPOSITORY	12		1
68016-321-13	Premier Value Hemorrhoidal	2 in 1 CARTON	SUPPOSITORY	2		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68016-321	PREMIER VALUE HEMORRHOIDAL (HEMORRHOIDAL RECTAL SUPPOSITORIES) SUPPOSITORY [CHAIN DRUG CONSORTIUM]	1	Legacy NDC, 2 package rows	20150326_8638a48e-9f90-4cab-abc1-5407afe498df.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68016-321-12	EA - Each	68016-321	1a6ae44e-c6c1-42f0-89f2-30174dbf5f67	1	2022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
COCOA BUTTER	ACTIVE INGREDIENT	512OYT1CRR	PREMIER VALUE HEMORRHOIDAL (HEMORRHOIDAL RECTAL SUPPOSITORIES) SUPPOSITORY [CHAIN DRUG CONSORTIUM]	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	PREMIER VALUE HEMORRHOIDAL (HEMORRHOIDAL RECTAL SUPPOSITORIES) SUPPOSITORY [CHAIN DRUG CONSORTIUM]	1
COCOA BUTTER	ACTIVE MOIETY	512OYT1CRR	PREMIER VALUE HEMORRHOIDAL (HEMORRHOIDAL RECTAL SUPPOSITORIES) SUPPOSITORY [CHAIN DRUG CONSORTIUM]	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	PREMIER VALUE HEMORRHOIDAL (HEMORRHOIDAL RECTAL SUPPOSITORIES) SUPPOSITORY [CHAIN DRUG CONSORTIUM]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	PREMIER VALUE HEMORRHOIDAL (HEMORRHOIDAL RECTAL SUPPOSITORIES) SUPPOSITORY [CHAIN DRUG CONSORTIUM]	1
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)	INACTIVE INGREDIENT	461P5CJN6T	PREMIER VALUE HEMORRHOIDAL (HEMORRHOIDAL RECTAL SUPPOSITORIES) SUPPOSITORY [CHAIN DRUG CONSORTIUM]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	PREMIER VALUE HEMORRHOIDAL (HEMORRHOIDAL RECTAL SUPPOSITORIES) SUPPOSITORY [CHAIN DRUG CONSORTIUM]	1

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 48 of 69 · 1,363 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TYLENOL COLD PLUS FLU SEVERE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	ef8a846d-4b29-4fd8-a683-fada04d0a2b9	2024-11-07	Warnings	Exact identifier unii: 04JA59TNSJ
Childrens TYLENOL COLD Plus FLU	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	9761c807-75a1-4498-a8c6-1f2b1c9ffde6	2024-11-07	Warnings	Exact identifier unii: 04JA59TNSJ
TYLENOL Cold Plus Mucus Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	24ac94e8-b223-424e-bcd2-9c027c8ff9ed	2024-11-07	Warnings	Exact identifier unii: 04JA59TNSJ
Rompe Pecho Max Multi Symptoms	ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN	EFFICIENT LABORATORIES INC	938e4e47-d2d9-4b0d-bf88-e9f41b501945	2024-11-07	Warnings	Exact identifier unii: 04JA59TNSJ
ED A-HIST	CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE	EDWARDS PHARMACEUTICALS, INC.	9147416d-9f3d-4ee4-a0c0-723e29830325	2024-11-07	Warnings	Exact identifier unii: 04JA59TNSJ
Leader Daytime Severe Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Cardinal Health 110, LLC. dba Leader	dd82a389-9ec5-4b3f-a9ea-1a56871ebd17	2024-11-07	Warnings	Exact identifier unii: 04JA59TNSJ
topcare day time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	1a8e2e03-e11b-4da1-945b-e2caadea7243	2024-11-07	Warnings	Exact identifier unii: 04JA59TNSJ
good sense severe day time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	L. Perrigo Company	44130a1b-63cc-42ac-9590-fdf21a12d164	2024-11-07	Warnings	Exact identifier unii: 04JA59TNSJ
foster and thrive daytime severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Strategic Sourcing Services LLC	a5ff1134-8985-4585-8e61-a5fd5f60afeb	2024-11-07	Warnings	Exact identifier unii: 04JA59TNSJ
basic care daytime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	50528d29-ce8c-4efb-a86c-17246b017db0	2024-11-07	Warnings	Exact identifier unii: 04JA59TNSJ
cooling severe daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	CVS Pharmacy	d4a21760-b2bd-4e26-bff0-6fc1b05d26b3	2024-11-07	Warnings	Exact identifier unii: 04JA59TNSJ
dg health day time severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Dolgencorp, LLC	60870311-3234-44ba-95dd-09cf4ea3d508	2024-11-07	Warnings	Exact identifier unii: 04JA59TNSJ
Childrens Sudafed PE NASAL DECONGESTANT	PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	4dfd46e4-b9f9-464d-aa47-e8fa9e526a5d	2024-11-04	Warnings	Exact identifier unii: 04JA59TNSJ
MyDerm	PENYLEPHRINE HCI, WITCH HAZEL, LIDOCAINE HCL,	Inspec Solution LLC.	2618eba1-9308-a666-e063-6394a90ac3d2	2024-11-04	Warnings	Exact identifier unii: 04JA59TNSJ
tussin severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	H E B	7cc2c136-d1b7-4658-99bb-73bb1d140261	2024-11-04	Warnings	Exact identifier unii: 04JA59TNSJ
dg health tussin	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Dolgencorp Inc	a5d0ee70-d528-4a53-bf01-7bb13b364ed0	2024-11-04	Warnings	Exact identifier unii: 04JA59TNSJ
basic care tussin cf severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	bba9a17d-eb87-46f3-acee-c9dd34e5bfd4	2024-11-04	Warnings	Exact identifier unii: 04JA59TNSJ
topcare tussin cf max	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	b553b7e6-933b-49e3-97d3-22a4643a04b9	2024-11-04	Warnings	Exact identifier unii: 04JA59TNSJ
basic care nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	1341744c-43c3-462b-b93c-1e46476fd935	2024-11-01	Warnings	Exact identifier unii: 04JA59TNSJ
Nighttime Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	CVS Pharmacy	43784616-1afd-4ff7-8fee-6ac389f616a2	2024-11-01	Warnings	Exact identifier unii: 04JA59TNSJ

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.