Relief OTC antacid

Product NDC: 69016-001
11-digit product format: 690160001
Labeler code: 69016
Product ID: 69016-001_e6cff231-ba97-4016-ab47-323461fb6d70
Type: HUMAN OTC DRUG
Nonproprietary name: CALCIUM CARBONATE, POTASSIUM BICARBONATE, SODIUM BICARBONATE
Dosage form: LIQUID
Route: ORAL
Labeler: Tummy Company, Inc.
Application: part331
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2014-05-28
Marketing end: 0000-00-00
Substance: CALCIUM CARBONATE; POTASSIUM BICARBONATE; SODIUM BICARBONATE
Active strength: 545 mg/118mL; mg/118mL; mg/118mL
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	69016-001		I	Inactivated by FDA	2026-10-05
excluded package	package	69016-001	69016-001-18	I	Inactivated by FDA	2026-10-05
excluded package	package	69016-001	69016-001-54	I	Inactivated by FDA	2026-10-05

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 2 · 66 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69016-001-18	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69016-001-54	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69016-001-18	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69016-001-54	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69016-001-18	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69016-001-54	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69016-001-18	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69016-001-54	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69016-001-18	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69016-001-54	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69016-001-18	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69016-001-54	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69016-001-18	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69016-001-54	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69016-001-18	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69016-001-54	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69016-001-18	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69016-001-54	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69016-001-18	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69016-001-54	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69016-001-18	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69016-001-54	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69016-001-18	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69016-001-54	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69016-001-18	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69016-001-54	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69016-001-18	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69016-001-54	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69016-001-18	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69016-001-54	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69016-001-18	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69016-001-54	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69016-001-18	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69016-001-54	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69016-001-18	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69016-001-54	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	69016-001-18	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	69016-001-54	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	69016-001-18	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	69016-001-54	`e2bbac7714bc…`	`27bdfed8d636…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9e37788c-b1bf-42ae-aac9-b60601606144	Product name	8	20260122
95250459-30e4-45c1-b08a-993044f49109	Product name	2	20250805
d9771140-739b-484b-ae64-b79528ff1211	Product name	3	20250801
bee4fa8d-8d82-423a-a0b5-40a89dd13a99	Product name	1	20250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767	Product name	4	20250516
efd58dcf-540a-4531-8766-e713129ca6f2	Product name	1	20250307
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2	Product name	5	20250304
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
1527ac37-808d-43be-a63e-74e1258dbe46	Product name	9	20250219
a21a21e5-f36d-4c1f-8918-def921b8f7e3	Product name	3	20250124
bed0530e-f939-4541-956b-6928a2f6404f	Product name	1	20241008
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	6	20240814
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
334fe8d2-68fb-4331-a576-420e302ec069	Product name	7	20240320
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
9fcb7a91-de07-4f00-aabf-e4d6fda403d5	Product name	8	20230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
0ec3537a-6c9b-432a-896c-b9ea8723049a	Product name	9	20200701
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
e92765c1-be81-432a-b909-1b10777ec378	Product name	1	20190208
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
7916de40-e296-41f0-b811-6d0df1a33e2c	Product name	9	20180627
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	2	20171212
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
26acd337-b838-40ac-bcbc-05c3b81c8712	Product name	1	20170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
0441a8f5-3835-497c-aedd-bc78cba56b2a	Product name	1	20150317
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69016-001-18	2019-11-27	C162847	48780-1	9855e2a2-4cf2-60a7-e053-dbdaa90a05bd	Relief OTC Antacid
69016-001-54	2019-11-27	C162847	48780-1	9855e2a2-4cf2-60a7-e053-dbdaa90a05bd	Relief OTC Antacid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69016-001-18	Relief OTC antacid	118 mL in 1 BOTTLE	LIQUID	118		1
69016-001-54	Relief OTC antacid	354 mL in 1 BOTTLE	LIQUID	354		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CALCIUM CARBONATE	ACTIVE INGREDIENT	H0G9379FGK	RELIEF OTC ANTACID (CALCIUM CARBONATE, POTASSIUM BICARBONATE, SODIUM BICARBONATE) LIQUID [TUMMY COMPANY, INC.]	1
POTASSIUM BICARBONATE	ACTIVE INGREDIENT	HM5Z15LEBN	RELIEF OTC ANTACID (CALCIUM CARBONATE, POTASSIUM BICARBONATE, SODIUM BICARBONATE) LIQUID [TUMMY COMPANY, INC.]	1
SODIUM BICARBONATE	ACTIVE INGREDIENT	8MDF5V39QO	RELIEF OTC ANTACID (CALCIUM CARBONATE, POTASSIUM BICARBONATE, SODIUM BICARBONATE) LIQUID [TUMMY COMPANY, INC.]	1
CALCIUM CATION	ACTIVE MOIETY	2M83C4R6ZB	RELIEF OTC ANTACID (CALCIUM CARBONATE, POTASSIUM BICARBONATE, SODIUM BICARBONATE) LIQUID [TUMMY COMPANY, INC.]	1
POTASSIUM CATION	ACTIVE MOIETY	295O53K152	RELIEF OTC ANTACID (CALCIUM CARBONATE, POTASSIUM BICARBONATE, SODIUM BICARBONATE) LIQUID [TUMMY COMPANY, INC.]	1
SODIUM CATION	ACTIVE MOIETY	LYR4M0NH37	RELIEF OTC ANTACID (CALCIUM CARBONATE, POTASSIUM BICARBONATE, SODIUM BICARBONATE) LIQUID [TUMMY COMPANY, INC.]	1
MAGNESIUM HYDROXIDE	INACTIVE INGREDIENT	NBZ3QY004S	RELIEF OTC ANTACID (CALCIUM CARBONATE, POTASSIUM BICARBONATE, SODIUM BICARBONATE) LIQUID [TUMMY COMPANY, INC.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	RELIEF OTC ANTACID (CALCIUM CARBONATE, POTASSIUM BICARBONATE, SODIUM BICARBONATE) LIQUID [TUMMY COMPANY, INC.]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	RELIEF OTC ANTACID (CALCIUM CARBONATE, POTASSIUM BICARBONATE, SODIUM BICARBONATE) LIQUID [TUMMY COMPANY, INC.]	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	RELIEF OTC ANTACID (CALCIUM CARBONATE, POTASSIUM BICARBONATE, SODIUM BICARBONATE) LIQUID [TUMMY COMPANY, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	RELIEF OTC ANTACID (CALCIUM CARBONATE, POTASSIUM BICARBONATE, SODIUM BICARBONATE) LIQUID [TUMMY COMPANY, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69016-001	RELIEF OTC ANTACID (CALCIUM CARBONATE, POTASSIUM BICARBONATE, SODIUM BICARBONATE) LIQUID [TUMMY COMPANY, INC.]	1	Legacy NDC, 2 package rows	20140529_3b876d55-f199-44cf-8963-7e895b3f5837.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
H0G9379FGK	CALCIUM CARBONATE	471-34-1	CALCIUM CARBONATE
HM5Z15LEBN	POTASSIUM BICARBONATE	298-14-6	POTASSIUM BICARBONATE
8MDF5V39QO	SODIUM BICARBONATE	144-55-8	SODIUM BICARBONATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1538288	calcium 545 MG / potassium 905 MG / sodium bicaronate 2110 MG in 118 mL Oral Suspension	PSN	3b876d55-f199-44cf-8963-7e895b3f5837	1
1538294	Fast Heartburn Relief OTC 545 MG / 905 MG / 2110 MG in 118 mL Oral Suspension	PSN	3b876d55-f199-44cf-8963-7e895b3f5837	1
1538294	calcium carbonate 4.62 MG/ML / potassium bicarbonate 7.67 MG/ML / sodium bicarbonate 17.9 MG/ML Oral Suspension [Fast Heartburn Relief OTC]	SBD	3b876d55-f199-44cf-8963-7e895b3f5837	1
1538288	calcium carbonate 4.62 MG/ML / potassium bicarbonate 7.67 MG/ML / sodium bicarbonate 17.9 MG/ML Oral Suspension	SCD	3b876d55-f199-44cf-8963-7e895b3f5837	1
1538288	calcium 545 MG / potassium 905 MG / sodium bicaronate 2110 MG per 118 ML Oral Suspension	SY	3b876d55-f199-44cf-8963-7e895b3f5837	1
1538288	Calcium Carbonate 4.62 MG/ML / K+ bicarbonate 7.67 MG/ML / NaHCO3 17.9 MG/ML Oral Suspension	SY	3b876d55-f199-44cf-8963-7e895b3f5837	1
1538294	Calcium Carbonate 4.62 MG/ML / K+ bicarbonate 7.67 MG/ML / NaHCO3 17.9 MG/ML Oral Suspension [Fast Heartburn Relief OTC]	SY	3b876d55-f199-44cf-8963-7e895b3f5837	1
1538288	Calcium Carbonate 4.62 MG/ML / Pot bicarbonate 7.67 MG/ML / NaHCO3 17.9 MG/ML Oral Suspension	SY	3b876d55-f199-44cf-8963-7e895b3f5837	1
1538294	Calcium Carbonate 4.62 MG/ML / Pot bicarbonate 7.67 MG/ML / NaHCO3 17.9 MG/ML Oral Suspension [Fast Heartburn Relief OTC]	SY	3b876d55-f199-44cf-8963-7e895b3f5837	1
1538294	Fast Heartburn Relief OTC (calcium carbonate 545 MG / potassium bicarbonate 905 MG / sodium bicarbonate 2110 MG per 118 ML) Oral Suspension	SY	3b876d55-f199-44cf-8963-7e895b3f5837	1
1538294	Fast Heartburn Relief OTC 545 MG / 905 MG / 2110 MG per 118 ML Oral Suspension	SY	3b876d55-f199-44cf-8963-7e895b3f5837	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
69016-001-18	69016000118	118 mL in 1 BOTTLE	118 ml	Historical
69016-001-54	69016000154	354 mL in 1 BOTTLE	354 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Relief OTC Antacid	Tummy Company, Inc. \| Alera Technologies Inc.	2014-05-29	HUMAN OTC DRUG LABEL	1