FDA.reportPublic FDA data

HEB Extra Strength

Product NDC
37808-510
11-digit product format
378080510
Labeler code
37808
Product ID
37808-510_bc8f027b-369d-4296-bd48-e6e12d5e79a1
Type
HUMAN OTC DRUG
Nonproprietary name
aluminum hydroxide and magnesium carbonate
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
HEB
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-03-20
Substance
ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE
Active strength
160; 105 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage37808-510-10557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage37808-510-108af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage37808-510-10834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage37808-510-101332a3947898…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
HEB Extra Strength
Brand name suffix
Cherry Flavor
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALUMINUM HYDROXIDE160 mg/1
MAGNESIUM CARBONATE105 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-09-17HEB ® Extra Strength Chewable Tablets Cherry Flavor
2024-09-17HEB ® Extra Strength Chewable Tablets Cherry Flavor
2023-01-30HEB ® Extra Strength Chewable Tablets Cherry Flavor
2023-01-30HEB ® Extra Strength Chewable Tablets Cherry Flavor

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-510-10HEB Extra StrengthCherry Flavor100 in 1 BOTTLE, PLASTICTABLET, CHEWABLE1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-510HEB EXTRA STRENGTH CHERRY FLAVOR (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE) TABLET, CHEWABLE [HEB]4Current NDC, Legacy NDC, 1 package rows20240919_6e10ad65-5baf-4763-befe-ed046bf914b5.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 31 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TUMS CHEWY BITESCALCIUM CARBONATE TABLET, CHEWABLELil' Drug Store Products, Inc.f67bd767-e9f1-2377-e053-2a95a90a0a2d2024-03-29WarningsExact identifier
application number: M001
Childrens Robitussin Cough and Cold CFDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLCfcd0a8e0-ac2a-039a-be3c-534195d6bcfd2024-03-17WarningsExact identifier
application number: M001
TUMSCALCIUM CARBONATEHaleon US Holdings LLC35f79dcf-1743-4d9f-aba5-5ead6b0563092024-03-15WarningsExact identifier
application number: M001
TUMS extra strength, smoothiesCALCIUM CARBONATEHaleon US Holdings LLC11078d7c-373b-4c7b-b33b-f1deba613fc12024-03-14WarningsExact identifier
application number: M001
Tums Chewy Bites Tropical Fruit SmoothieCALCIUM CARBONATEHaleon US Holdings LLC500f821e-dd27-4c7c-b629-a826b2e57c132024-03-11WarningsExact identifier
application number: M001
TUMSCALCIUM CARBONATEHaleon US Holdings LLC3988e3f8-b276-43a0-bdd3-01ddd422c9862024-03-03WarningsExact identifier
application number: M001
TUMS SmoothiesCALCIUM CARBONATEHaleon US Holdings LLC9e54f687-4072-42fd-a14b-af67fe8b6cc42024-03-03WarningsExact identifier
application number: M001
Tums Regular StrengthCALCIUM CARBONATEHaleon US Holdings LLCac80f627-3f51-425b-8c75-e07363048b002024-03-03WarningsExact identifier
application number: M001
Tums Chewy Bites Mixed FruitCALCIUM CARBONATEHaleon US Holdings LLCd341b832-edcf-4cb2-96e1-c303b030c59a2024-03-02WarningsExact identifier
application number: M001
Tums Chewy BitesCALCIUM CARBONATEHaleon US Holdings LLC5090f60f-fa98-470b-bafd-bb64e6b28fcc2024-03-02WarningsExact identifier
application number: M001
Tums Chewy BitesCALCIUM CARBONATEHaleon US Holdings LLC453ceee1-414b-4f4c-8408-eb540a79ca052024-03-02WarningsExact identifier
application number: M001
Tums Chewy Bites Berry ShakeCALCIUM CARBONATEHaleon US Holdings LLC9043983c-7ee4-4971-8885-36f814bb570f2024-03-02WarningsExact identifier
application number: M001
Tums Chewy DelightsCALCIUM CARBONATEHaleon US Holdings LLC189850d0-6f06-45bd-bd7e-9063ee580d0b2024-03-02WarningsExact identifier
application number: M001
Sodium BicarbonateSODIUM BICARBONATEBryant Ranch Prepack4493d7c5-f2c3-416e-a5c1-35398fc7f61d2024-02-29Boxed warning, WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACID AND ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONESTRATEGIC SOURCING SERVICES LLCfe04c244-d9b8-2800-e053-6294a90aeedc2024-02-06WarningsExact identifier
application number: M001
Mylanta ClassicCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONEInfirst Healthcare Inc.10a4cf29-39ed-87c3-e063-6394a90a49732024-02-05WarningsExact identifier
application number: M001
Mylanta Vanilla CaramelCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONEInfirst Healthcare Inc.10a66d74-74b4-3f8d-e063-6394a90a7f002024-02-05WarningsExact identifier
application number: M001
Mylanta Maximum Strength Vanilla Caramel FlavorANTACID AND ANTI GAS ALUMINUM HYDROXIDE MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.ace5cae4-3a78-41c3-987d-59ce22dca2ac2024-01-01WarningsExact identifier
application number: M001
Mylanta Coat and CoolCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONEINFIRST HEALTHCARE INC.b6571f7f-e1ea-4034-a46c-4de1d01beec32024-01-01WarningsExact identifier
application number: M001
Sodium BicarbonateSODIUM BICARBONATEPharma Nobis, LLCe42f674b-1a70-6a3c-e053-2995a90afa722023-12-22WarningsExact identifier
application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308072aluminum hydroxide 160 MG / magnesium carbonate 105 MG Chewable TabletPSN6e10ad65-5baf-4763-befe-ed046bf914b55
308072aluminum hydroxide 160 MG / magnesium carbonate 105 MG Chewable TabletSCD6e10ad65-5baf-4763-befe-ed046bf914b55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
37808-510-1037808051010100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (37808-510-10) 2019-03-200000-00-00NoNoCurrent